U.S. patent application number 11/382465 was filed with the patent office on 2006-11-30 for nasal cavity treatment apparatus.
Invention is credited to Michael Gertner, Erica Rogers.
Application Number | 20060271024 11/382465 |
Document ID | / |
Family ID | 36697938 |
Filed Date | 2006-11-30 |
United States Patent
Application |
20060271024 |
Kind Code |
A1 |
Gertner; Michael ; et
al. |
November 30, 2006 |
Nasal Cavity Treatment Apparatus
Abstract
An optical therapy device for providing therapeutic light to a
person's nasal cavity includes a body and at least one UV light
source in or on the body. A distal end of the body is configured to
be inserted into the person's nasal cavity. The body can be
configured to be hand-held. The optical therapy device is
configured such that the UV light source emits a dose of UV light
toward tissue in the patient's nasal cavity.
Inventors: |
Gertner; Michael; (Menlo
Park, CA) ; Rogers; Erica; (Emerald Hills,
CA) |
Correspondence
Address: |
WILSON SONSINI GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO
CA
94304-1050
US
|
Family ID: |
36697938 |
Appl. No.: |
11/382465 |
Filed: |
May 9, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11152946 |
Jun 14, 2005 |
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11382465 |
May 9, 2006 |
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60646818 |
Jan 25, 2005 |
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60661688 |
Mar 14, 2005 |
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Current U.S.
Class: |
606/2 |
Current CPC
Class: |
A61N 2005/0605 20130101;
A61N 2005/0607 20130101; A61N 5/0616 20130101; A61N 2005/0611
20130101; A61N 2005/0609 20130101; A61N 2005/0644 20130101; A61N
5/0624 20130101; A61N 2005/0651 20130101; A61N 2005/0606 20130101;
A61N 2005/0645 20130101; A61N 2005/0661 20130101; A61N 5/0603
20130101; A61N 2005/0608 20130101 |
Class at
Publication: |
606/002 |
International
Class: |
A61B 18/18 20060101
A61B018/18 |
Claims
1. A treatment apparatus for a nasal cavity comprising: (a) a
tubular member having a proximal end and a distal end; and (b) an
expandable member positioned at the distal end of the tubular
member adapted to transfer energy to or from the nasal cavity of a
patient.
2. The treatment apparatus of claim 1 wherein the apparatus is
adapted to treat one or more paranasal sinuses of the nasal
cavity.
3. The apparatus of claim 1 wherein the apparatus is adapted to
travel over a guidewire.
4. The apparatus of claim 1 wherein the expandable member is
constructed from a material adapted to permit energy transfer from
the expandable member, through the material, and to the nasal
cavity structure or from the nasal cavity structure, through the
material and to the expandable member.
5. The treatment apparatus of claim 1 wherein the expandable member
is constructed from a material adapted to facilitate energy
transfer from the expandable member to the nasal cavity or to the
expandable structure from the nasal cavity.
6. The treatment apparatus of claim 1 wherein the tube is
flexible.
7. The treatment apparatus of claim 1 wherein the tubular member
has an angular tip.
8. The treatment apparatus of claim 1 wherein the energy
transferred is heat energy.
9. The treatment apparatus of claim 1 wherein the energy
transferred is light energy.
10. The treatment apparatus of claim 1 wherein the apparatus is
adapted to further comprise one or more semiconductor structures at
the distal end.
11. The treatment apparatus of claim 10 wherein the semiconductor
structure is an LED.
12. The treatment apparatus of claim 1 further comprising a
mechanized device positioned at the distal end which automates
energy delivery to the nasal cavity.
13. A method of treating a nasal cavity comprising the steps of:
(a) inserting an apparatus comprising a tubular member having a
proximal end and a distal end, and an expandable member positioned
at the distal end of the tubular member adapted to transfer energy
through a material of the expandable member; (b) expanding the
expandable member within the nasal cavity of the patient to expose
a surface area of a structure; (c) transferring energy through the
expandable member to a structure within the nasal cavity.
14. The method of treating a nasal cavity according to claim 13
wherein the transferring step comprises withdrawing energy from the
nasal structure.
15. The method of treating a nasal cavity according to claim 13
wherein the transferring step comprises cooling the structure
within the nasal cavity.
16. The method of treating a nasal cavity according to claim 13
wherein the tubular member is flexible.
17. The method of treating a nasal cavity according to claim 13
wherein the distal end of the tubular member is adapted to access a
sinus cavity.
18. The method of treating a nasal cavity according to claim 13
wherein the distal end of the tubular member is angled.
19. The method of treating a nasal cavity according to claim 13
wherein the distal end of the tubular member further comprises a
mechanism which automates the dose of energy delivered to the nasal
cavity.
20. The method of treating a nasal cavity according to claim 13
further comprising the step of accessing a nasal cavity with a
guidewire prior to inserting an apparatus comprising a tubular
member into the nasal cavity of the patient.
21. The method of treating a nasal cavity according to claim 20
wherein the expanding step comprises applying pressure to the
mucosa of the nasal cavity to transfer energy in a substantially
even manner.
22. A method of treating a disease of the sinuses comprising the
steps of: (a) inserting an apparatus comprising a tubular member
having a proximal end, a distal end, and an expandable member
positioned at the distal end of the tubular member adapted to
transfer energy within a nasal cavity of a patient; (b) expanding
the expandable member within the nasal cavity of the patient to
substantially contact the mucosa of the nasal cavity; and (c)
transferring energy through the expandable device to the structure
within the nasal cavity.
23. The method of claim 22 further comprising the step of accessing
a nasal cavity with a guidewire prior to inserting an apparatus
comprising a tubular member into the nasal cavity of the
patient.
24. The method of claim 22 further comprising the step of adding
heat to the structure of the sinus cavity through the expandable
member.
25. The method of claim 22 further comprising the step of applying
light through the expandable member.
26. The method of claim 25 wherein the light is ultraviolet
light.
27. The method of claim 26 wherein the ultraviolet light has a
wavelength below 320 nm.
28. The method of claim 22 wherein the structure is the mucosa of
the nasal cavity.
29. The method of claim 22 wherein the structure is a nasal
polyp.
30. The method of claim 22 wherein the structure is one or more of
the turbinates.
31. The method of claim 22 wherein the apparatus comprises an
LED
32. A treatment apparatus for a nasal cavity comprising: (a) a
tubular member having a proximal end and a distal end; and (b) a
device positioned at the distal end of the tubular member adapted
to transfer energy to or from the nasal cavity of a patient.
33. The treatment apparatus of claim 32 wherein said device emits
electromagnetic radiation with wavelengths lower than 400 nm
34. The treatment apparatus of claim 32 wherein said device is an
LED
35. The treatment apparatus of claim 32 wherein said device is a
cooling device.
36. The treatment apparatus of claim 32 wherein said device emits
electromagnetic radiation with wavelengths greater 700 nm.
37. The treatment apparatus of claim 36 wherein said device is an
LED.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a Continuation of U.S. patent
application Ser. No. 11/152,946, filed Jun. 14, 2005. This
Application also claims the priority benefit of U.S. Provisional
Application No. 60/646,818, filed 1/25/05, and U.S. Provisional
Application No. 60/661,688, filed Mar. 14, 2005, all of which are
incorporated by reference herein in their entireties.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The present invention relates generally to optical therapies
and phototherapies for treatment of diseases and physiological
disorders, such as, for example, rhinitis.
[0004] 2. Background of Invention
[0005] Phototherapy has been used to treat skin disorders, such as
psoriasis and atopic dermatitis. As the understanding of the
pathophysiologic mechanisms of disease has become better
understood, it has been learned that psoriasis is mediated by an
immune reaction orchestrated by activated T-cells specific for an
antigen. It has also been learned that the T cells undergo
apoptosis (or programmed cell death) in response to ultraviolet
light therapy (see, for example, Ozawa et al, 312-Nanometer
Ultraviolet B Light (Narrow-Band UVB) Induces Apoptosis of T Cells
within Psoriatic Lesions, 189(4) J. Exp. Med. 711-18, which is
incorporated by reference herein). Ultraviolet-B (UVB) light,
generally in the range of about 280 nm to about 320 nm, has also
been shown to induce cytokines such as interleukin 10 (IL10) and
tumor necrosis factor alpha (TNF-.alpha.) (see, for example,
Narrow-Band Ultraviolet B and Broad-Band Ultraviolet A Phototherapy
in Adult Atopic Eczema: A Randomized Controlled Trial, 357 Lancet
2012-16 (2001), which is incorporated by reference herein).
[0006] Ultraviolet therapy was also studied in the context of
atopic dermatitis and was found to have a beneficial effect (see,
for example, Narrow-Band Ultraviolet B and Broad-Band Ultraviolet A
Phototherapy in Adult Atopic Eczema: A Randomized Controlled Trial,
357 Lancet 2012-16 (2001) and UVB Phototherapy of Atopic
Dermatitis, 119 British Journal of Dermatology 697-705 (1988), both
of which are incorporated by reference herein). Similar mechanistic
actions of ultraviolet light are invoked in atopic dermatitis as in
psoriasis; that is, apoptosis of immune regulatory cells.
Additional mechanisms are invoked for atopic dermatitis as well.
For example, Guhl, et al., (Bivalent Effect of UV Light on Human
Skin Mast Cells--Low-Level Mediator Release at Baseline but Potent
Suppression upon Mast Cell Triggering, 124 J. Invest. Dermatol.
453-56 (2005), which is incorporated by reference,) showed that
mast cells from skin are sensitive to UVA light having a wavelength
in the range of 320 nm to 400 nm, and that these wavelengths
(albeit at higher doses) can inhibit the degranulation of mast
cells, thereby preventing histamine release.
[0007] More recent work in atopic dermatitis has revealed that
light concentrated in the blue range (which is generally light
having a wavelength in the range of about 400 nm to about 450 nm)
can also improve the symptomatology of atopic dermatitis. See, for
example, Krutman, et al., Ultraviolet-Free Phototherapy, 21
Photodermatology, Photoimmunology, and Photomedicine 59-61 (2005),
which is incorporated by reference. Krutman, et al. showed that the
application 40 J/cm2 of essentially blue light can dramatically
improve the symptomatology of atopic dermatitis even when one
observes patients further out over time.
SUMMARY OF THE INVENTION
[0008] In one embodiment, an optical therapy device for providing
therapeutic light to a person's nasal cavity comprises a body,
wherein at least a distal end of the body is configured to be
inserted into the person's nasal cavity and wherein said body is
further configured to be hand-held; and at least one UV light
source positioned in or on said body, wherein said device is
configured such that said at least one UV light source emits a dose
of UV light toward tissue in said patient's nasal cavity when the
distal end of the body is positioned in the nasal cavity.
[0009] The body may further comprise a microcontroller electrically
coupled to the at least one UV light source. The at least one UV
light source may comprise a solid-state light source, a light
emitting diode (LED), at least one of a mercury vapor lamp and a UV
enhanced halogen lamp, a UVA light source, a UVB light source,
and/or a UVA light source and a UVB light source.
[0010] In one embodiment, the optical therapy device further
comprises a light conditioner. The light conditioner may comprise a
light scattering medium, a light focusing element, a lens, a light
reflecting element, a mirror, a filter, an optical filter and/or a
sheath.
[0011] In another embodiment, the optical therapy device body
further comprises a body proximal portion and a body distal
portion, wherein the at least one UV light source is located at the
body distal portion. In yet another embodiment, the optical therapy
device body further comprises a body proximal portion and a body
distal portion, the body distal portion comprising the distal end
of the body, wherein the at least one UV light source is located at
the body proximal portion. The body may be elongate and have a
length extending from a proximal end of the body to the distal end,
and the length may be less than or equal to about 30 cm.
[0012] In another embodiment, the optical therapy device body
further comprises a body proximal portion and a body distal
portion, the body distal portion comprising the distal end of the
body, wherein said optical therapy device further comprises a
window, wherein the window is located at or near the body distal
portion. The window may be at least partially transmissive of UV
light generated by the UV light source.
[0013] The optical therapy device may further comprise a sheath,
wherein the sheath is configured to at least partially cover the
body. The sheath may be manufactured using a mold. In addition, the
sheath may comprise at least one material that is at least
partially transmissive of UV light. The at least one material may
condition the light.
[0014] In another embodiment, the optical therapy device further
comprises a controller, wherein said controller controls a
parameter of the dose. The controller may be in or on said body.
The parameter may comprise at least one of an on-time and an
off-time of the optical therapy device and/or a sequence for
activating said at least one UV light source. The controller may
record a total number of doses and prevents the emission of the
dose after the total number of doses reaches a predetermined
level.
[0015] In another embodiment, the optical therapy device further
comprises a power supply for powering said at least one UV light
source, wherein said power supply is positioned in or on the body.
In yet another embodiment, the optical therapy device further
comprises a cooling module that dissipates heat generated by said
optical therapy device. The cooling module may comprise a heat pipe
and/or an active cooling device.
[0016] In another embodiment, the optical therapy device further
comprises a visible light source. The visible light source may
comprise at least one LED.
[0017] In another embodiment, the at least one UV light source
provides a UVA percentage and a UVB percentage of total optical
energy delivered by the optical therapy device, and the UVB
percentage is less than said UVA percentage. In another embodiment,
the at least one UV light source comprises an LED chipset, wherein
the LED chipset comprises at least one UVA LED that emits UVA light
and at least one UVB LED that emits UVB light.
[0018] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: a body,
wherein at least a portion of the body is configured to be inserted
into the nasal cavity; at least one UV light source positioned on
or in said body, wherein said at least one UV light source
generates light that is emitted toward tissue inside said nasal
cavity when the portion of the body is inserted into the nasal
cavity; and a light conditioner configured to condition light
emitted from the at least one UV light source.
[0019] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: a body,
wherein at least a portion of the body is configured to be inserted
into the nasal cavity; at least one UV light source positioned on
or in said body, wherein said at least one UV light source
generates light that is emitted toward tissue inside said nasal
cavity; and a sheath, configured to cover at least a portion of the
body.
[0020] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: a body,
comprising a distal portion, wherein at least the distal portion is
configured to be inserted into the nasal cavity; and at least one
UV light source that generates UV light, said UV light source
positioned at said distal portion.
[0021] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: a body,
wherein at least a portion of the body is configured to be inserted
into the nasal cavity; and at least one solid-state UV light source
positioned in or on said body, wherein said at least one
solid-state UV light source is configured to emit light into the
nasal cavity when the portion of the body is inserted into the
nasal cavity.
[0022] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: an
elongate body, wherein at least a distal end of the elongate body
is configured to be inserted into the nasal cavity, wherein the
elongate body has a length, extending from a proximal end of the
body to the distal end, that is less than or equal to about 30 cm;
and at least one UV light source positioned in or on said elongate
body, wherein said at least one UV light source is configured to
emit light into the nasal cavity when the distal end is inserted
into the nasal cavity.
[0023] In yet another embodiment, an optical therapy device for
providing therapeutic light to a person's body cavity, comprises: a
body, wherein at least a portion of the body is configured to be
inserted into the person's body cavity; at least one UV light
source positioned in or on said body, wherein said at least one UV
light source is configured to emit light into the person's body
cavity; and a light conditioner, configured to condition light
emitted from the at least one UV light source.
[0024] In another embodiment, an optical therapy device for
providing therapeutic light to a person's body cavity, comprises: a
body, wherein at least a portion of the body is configured to be
inserted into the person's body cavity; at least one UV light
source positioned in or on said body, wherein said at least one UV
light source is configured to emit light into the person's body
cavity; and a sheath, configured to cover at least a portion of the
body.
[0025] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: a body,
wherein at least a distal portion of the body is configured to be
inserted into the nasal cavity; at least one UV light source
located at the distal portion, said optical therapy device being
configured to activate said at least one UV light source to
generate a therapeutic dose of UV light to tissue in the nasal
cavity when the portion of the body is positioned in the nasal
cavity.
[0026] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: an
elongate body, wherein at least a distal end of the elongate body
is configured to be inserted into the nasal cavity; and a light
conditioner configured to condition light emitted from at least one
UV light source located in or on the body, wherein the elongate
body has a length, from a proximal end of the body to the distal
end, that is less than or equal to about 30 cm.
[0027] In another embodiment, an optical therapy device for
providing therapeutic light to a nasal cavity, comprises: an
elongate body, wherein at least a distal end of the elongate body
is configured to be inserted into the nasal cavity; and a sheath,
configured to cover at least a portion of the body, wherein the
elongate body has a length, from a proximal end of the body to the
distal end, that is less than or equal to about 30 cm.
[0028] In yet another embodiment, an optical therapy device for
providing therapeutic light to a mammal's nasal cavity, the optical
therapy device comprises: inserting means for delivering light to
the mammal's nasal cavity, said inserting means comprising an
insertion portion that is configured to be wholly inserted into the
mammal's nasal cavity; and UV light-emission means, positioned on
or in said insertion portion of said inserting means, such that
said UV light-emission means generates UV light that is emitted
toward tissue in said mammal's nasal cavity when the insertion
portion is inserted into the patient's nasal cavity.
[0029] In another embodiment, a method of delivering optical
therapy to a patient, comprises: providing an optical therapy
device, said optical therapy device comprising: a body that is
configured to be hand-held, said body comprising a distal portion,
wherein at least the distal portion is configured to be inserted
into the patient's nasal cavity; and at least one UV light source
positioned in or on said body; inserting the optical therapy device
in the patient's nasal cavity; and emitting UV light for a period
of time from said UV light source toward tissue inside said
patient's nasal cavity. In another embodiment of the method, the at
least one UV light source comprises a light emitting diode.
[0030] In another embodiment, a method of delivering optical
therapy to a patient, comprises: providing an optical therapy
device, said optical therapy device comprising: an elongate body,
wherein at least a distal end of the elongate body is configured to
be inserted into the person's nasal cavity, and wherein the
elongate body has a length, from a proximal end of the body to the
distal end, that is less than or equal to about 30 cm; and at least
one UV light source located in or on said elongate body; and
emitting a dose of UV light from said UV light source toward tissue
in said patient's nasal cavity when the distal end of the body is
positioned in the nasal cavity. In another embodiment of the
method, the at least one UV light source comprises is a light
emitting diode.
[0031] In one embodiment, an optical therapy device includes a
proximal end, a distal end, a connecting structure, and one or more
independently controllable light emitting semiconductor devices at
the distal end, wherein at least one independently controllable
light emitting semiconductor device emits electromagnetic radiation
in the range of between about 200 nm and about 400 nm. The device
may be further configured for medical use and/or for research use.
In one embodiment, at least one of said one or more of the light
emitting semiconductor devices emits electromagnetic radiation in
the range of between about 250 nm and about 350 nm. In another
embodiment, at least one of said one or more of the light emitting
semiconductor elements emits electromagnetic radiation in the range
of between about 270 nm and about 320 nm. In another embodiment, at
least one of said one or more light emitting semiconductor elements
emits electromagnetic radiation between about 300 nm and about 315
nm.
[0032] In another embodiment, the device also includes a controller
configured to modulate the spectral characteristics of the device.
At least one light emitting semiconductor devices may emit
electromagnetic radiation with more than one individually
controllable wavelength. The medical use may be an optical therapy.
The device may be configured to enter a body cavity. The
electromagnetic radiation of the independently controllable
semiconductor device may emit directly into a body cavity. The
electromagnetic radiation of the at least one independently
controllable semiconductor device may emit electromagnetic
radiation into a body cavity without an optical guidance system.
The connector of the device can include a rigid and/or a flexible
material. In one embodiment, the connector includes a catheter,
laparoscope, and/or an endoscope.
[0033] In another embodiment of the present invention, an optical
therapy device includes a proximal end, a distal end, and a
connecting structure between the proximal and distal ends, wherein
the distal end includes more than one individually controllable
light emitting semiconductor devices. The device may be configured
for medical and/or research use, and may further comprise a control
system to independently control light emitting semiconductor
devices. The device may be configured to apply light therapy to a
body surface. The proximal end may be configured to control the
orientation of the distal end.
[0034] In one embodiment of the present invention, a method of
treating a patient includes providing a device having a proximal
end, a distal end, and at least one light-emitting semiconductor
device at the distal end, and applying the device to a patient such
that the distal end resides within 20 mm of a body surface.
[0035] In one embodiment of the method, the at least one
light-emitting semiconductor device emits electromagnetic radiation
with a wavelength in the range of between about 200 nm and about
400 nm. In one embodiment, the body surface is the skin. In another
embodiment, the body surface is a mucosal surface of an airway. In
yet another embodiment, the mucosal surface of the airway is the
nasal mucosa. The mucosal surface may be the mucosa of a paranasal
sinus. As used herein, "nasal cavity" includes its ordinary meaning
and can also include the paranasal sinuses and nearby anatomic
structures. Additionally, the body surface may be a tract created
by a man-made device, such as an indwelling catheter. The body
surface may be the surface of an implanted device, such as the
skin. In one embodiment, a synergistic moiety is introduced into
the body surface prior to applying said device.
[0036] In one embodiment, a method of treating a patient includes
providing a device including a proximal end, a distal end, and at
least one semiconductor element at the distal end wherein the at
least one semiconductor element or combination of semiconductor
elements emit more than one individually controllable wavelength
and applying the device to a patient. The method may further
include applying the device to the patient to treat or prevent a
medical condition. In one embodiment, the medical condition is
rhinitis, sinusitis, a disorder of the anterior portion of the eye,
a state of infection, an allergic condition, sinusitis, a state of
organ rejection, and/or a dermatologic disorder.
[0037] In one embodiment, a method of treating a patient includes
providing a device having a photon generator, a supply of power,
and a mechanism of attachment to the patient, and attaching the
device to a patient. The method may further include applying
optical therapy to a patient with said device.
[0038] In another embodiment, a method of treating a patient
includes providing a device having photon generator, a supply of
power, a mechanism of attachment to the patient, and a system to
control the spectral output of the device, and applying optical
therapy to the patient. The method may further include programming
said controller to deliver a custom spectral output.
[0039] In another embodiment, a method of treating a patient
includes providing a device including a semiconductor based photon
generator, a supply of power, a mechanism of attachment to the
patient, and a system to control the spectral output of the device,
and applying optical therapy to the patient.
[0040] In one embodiment, a method of treating a patient includes
providing a device having at least one semiconductor-based
generator of photons that emits light having a wavelength in the
range of between about 200 nm and about 400 nm, and a mechanism of
attachment to the patient. The method may further include treating
a patient with optical therapy.
[0041] In one embodiment, a system for delivering optical therapy
includes an array of individually controllable light emitting
semi-conductor devices, a controller, and a handheld probe, wherein
the spectral output of the system is programmable with the
controller. The controller may be programmable to deliver one or
more doses of optical therapy. The controller may be configured to
deliver enough power to destroy said light emitting semiconductor
devices after a defined number of optical therapy doses. The system
may further include an optical guidance system.
[0042] At least one individually controllable semiconductor element
may emit electromagnetic radiation having a wavelength in the range
of between about 200 nm and about 400 nm. The at least one
individually controllable semiconductor device may emit
electromagnetic radiation having a wavelength in the range of
between about 250 nm and about 350 nm. The system may further
include a wireless transmitter in communication with said
controller.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] FIG. 1A is a cross-sectional view of an optical therapy
device in accordance with one embodiment of the present
invention;
[0044] FIG. 1B is a cross-sectional view of the sheath of the
optical therapy device of FIG. 1A;
[0045] FIG. 2 illustrates an optical therapy system in accordance
with another embodiment of the present invention;
[0046] FIGS. 3A and 3B illustrate an optical therapy device
inserted into a person's nasal cavity;
[0047] FIGS. 4 and 5A are cross-sectional views of optical therapy
devices in accordance with embodiments of the present
invention;
[0048] FIG. 5B is a cross-sectional view taken along line 5B-5B of
FIG. 5A;
[0049] FIGS. 6A-7A are cross-sectional views of optical therapy
device in accordance with additional embodiments of the present
invention;
[0050] FIG. 7B is a cross-sectional view taken along line 7B-7B of
FIG. 7A;
[0051] FIG. 8A is a cross-sectional view of an optical therapy
device in accordance with other embodiments of the present
invention;
[0052] FIG. 8B is a cross-sectional view taken along line 8B-8B of
FIG. 8A;
[0053] FIGS. 9A-9H illustrate optical therapy devices having
different tubes in accordance with additional embodiments of the
present invention and generally configured to treat the sinuses of
a patient;
[0054] FIGS. 91-9J illustrate another optical therapy device in
accordance with another embodiment of the present invention;
[0055] FIG. 10A illustrates a light emitting diode (LED) device in
accordance with one embodiment of the present invention;
[0056] FIG. 10B is an exploded view of the LED of FIG. 10A;
[0057] FIG. 10C illustrates a spectroradiometer measurement of the
optical output from an LED device, such as the LED of FIG. 10A,
having a peak at about 308 nm;
[0058] FIG. 10D illustrates the output from one embodiment of a set
of three white-light emitting LEDs (wLED);
[0059] FIG. 10E illustrates a spectroradiometer measurement of the
optical output from a multi-chip LED (mLED);
[0060] FIGS. 11A and 11B are cross-sectional views of an optical
therapy device according to additional embodiments of the present
invention;
[0061] FIG. 11C is a cross-sectional view taken along line 11C-11C
of FIG. 11B;
[0062] FIG. 11D is a cross-sectional view taken along line 11D-11D
of FIG. 11B;
[0063] FIG. 12A illustrates another embodiment of an optical
therapy device positioned at the end of a flexible medical
device;
[0064] FIG. 12B illustrates one embodiment of an indwelling
catheter according to another embodiment of the present
invention;
[0065] FIG. 12C illustrates one embodiment of an optical therapy
device located inside of an at least partially
optically-transparent balloon;
[0066] FIGS. 13A-13B illustrates one embodiment of an optical
therapy system to treat transplanted organs, such as transplanted
kidney;
[0067] FIGS. 14A-14B illustrate another embodiment of an optical
therapy device used to treat disorders of the eye;
[0068] FIG. 15A illustrates an optical therapy device delivering
optical therapy to a patient's skin;
[0069] FIG. 15B illustrates a wearable optical therapy device in
the form of a wrist bracelet;
[0070] FIG. 15C illustrates an optical therapy device delivering
optical therapy to a patient's fingernail; and
[0071] FIG. 15D illustrates an optical therapy device in the form
of an adhesive bandage.
DETAILED DESCRIPTION OF THE INVENTION
The Atopic Diseases
[0072] Atopy refers to an inherited propensity to respond
immunologically to many common, naturally occurring inhaled and
ingested allergens with the continual production of IgE antibodies.
Allergic rhinitis and asthma are the most common clinical
manifestations of atopic disease affecting approximately 50 million
people in the United States alone. Atopic dermatitis, or eczema, is
less common, but nonetheless afflicts an estimated 20 million
people in the U.S. There is a great deal of overlap among patients
with atopic disease. Patients with atopic asthma have a greater
likelihood of developing allergic rhinitis and dermatitis, and vice
versa. Indeed, the pathophysiology for all atopic diseases is
generally the same whether or not the affected organ is the skin,
the nose, the lungs, or the gastrointestinal tract. Contact with an
allergic particle (for example, pollen, cat dander, or food
particle) reacts with an associated antibody on the mast cell,
which leads to prompt mediator release and clinical symptoms. The
IgE antibody response is perpetuated by T cells (antigen specific
memory cells or other regulatory cells), which also have
specificity for the allergens.
[0073] Kemeny, et al., in Intranasal Irradiation with the Xenon
Chloride Ultraviolet B Laser Improves Allergic Rhinitis, 75 Journal
of Photochemistry and Photobiology B: Biology 137-144 (2004) and
Koreck, et al., in Rhinophototherapy: A New Therapeutic Tool for
the Management of Allergic Rhinitis, Journal of Allergy and
Clinical Immunology (March 2005), both of which are incorporated by
reference, describe a treatment for allergic rhinitis using the
same theory espoused for the efficacy of ultraviolet light in
atopic dermatitis. Their placebo-controlled study showed the
efficacy of ultraviolet therapy to treat allergic, or atopic,
rhinitis over the course of an allergy season.
Ultraviolet Therapy, Other Skin Disorders, and Other Diseases
[0074] Ultraviolet A-1 therapy (typically performed with light
having a wavelength in the range of about 340 nm to about 400 nm)
has also been shown to be useful in the treatment of disorders of
excess collagen production such as scleroderma. In this disease
state, the phototherapy has been shown to induce collagenases
within the skin which ultimately leads to softer and more compliant
skin (See, for example, UVA-1 Phototherapy, 21 Photodermatology,
Photoimmunology, and Photomedicine 103-08 (2003), which is
incorporated by reference).
[0075] Collagenases are also present in other organ systems where
scarring is a problem as well. For example, the myocardium is
endowed with a very active collagenase system which has been shown
to affect the scarring process in disease states such as diastolic
heart failure and other cardiomyopathies (See, for example,
Fibrosis as a Therapeutic Target Post-Myocardial Infarction, 11(4)
Curr Pharm Des. 477-87, which is incorporated by reference).
Similarly, interstitial bladder disease also results from
imbalances in the collagenase system (Peters, et al., Dysregulated
Proteolytic Balance as the Basis of Excess Extracellular in
Fibrotic Disease, Am. J. Physiol. June, 272 (6 pt 2): R1960-5,
which is incorporated by reference).
Antimicrobial Effects of Ultraviolet Light
[0076] Infection of a patient takes many forms. Typically, acute
bacterial infections are rather easily controlled using standard
antibiotic therapies. Chronic infections, on the other hand, are
often very difficult to control for several reasons: 1) the
antimicrobial flora of chronically infected regions of the body
often develop resistance to standard antibiotics due to multiple
attempts to treat the flora with antimicrobial therapy; 2) the
microbes often form biofilms to protect themselves against the
protective mechanisms of the patient; 3) many chronic infections
occur around man-made implants which often serve as a nidus for
microbes to proliferate as well as form biofilms. Examples of
chronic infections include: sinusitis (including chronic bacterial
and fungal), vascular access catheter infections, chemotherapy port
infections, peritoneal dialysis access catheter infections, vaginal
yeast infections, chronic skin ulcerations and wounds,
ventriculo-peritoneal shunts, sinus tracts in patients with Crohn's
disease, chronic bronchitis and COPD, helicobacter pylori
infections of the stomach, aerobic and anaerobic infections of the
small intestine and colon, chronic ear infections, skin ulcers
(e.g., diabetic skin ulcers), and fungal infections of the nail
beds. There is also increasing evidence that atherosclerosis is
caused by infections by micro-organisms such as Chlamydia.
[0077] It is well-known that ultraviolet light (typically the
longer wavelengths of the UVC region of the spectrum, 250-280 nm)
has the ability to sterilize and destroy microbes through
multifactorial mechanisms. To destroy viruses and bacteria, a dose
of 2.5-50 mJ/cm2 can be utilized; for yeast, a dose of 6.6-35.6
.mu.mJ/cm2 is typically utilized; and for molds, spores, fungi, and
algae, a dose of 1-330 mJ/cm2 is typically utilized.
Lighting Technologies
[0078] Advanced lighting technologies, including solid state
devices (e.g., light emitting diodes, electroluminescent inorganic
materials, organic diodes, etc.), miniature halogen lamps,
miniature mercury vapor and fluorescent lamps, collectively offer
the potential for less expensive and more flexible
phototherapeutical units. Solid state technology has already
revolutionized areas outside medicine and holds a great deal of
promise inside the biomedical sciences.
[0079] Light emitting semiconductor devices (e.g., light emitting
diodes or LEDs) offer many advantages in the biomedical sciences.
For example, they are generally less expensive than traditional
light sources in terms of cost per lumen of light; they are
generally smaller, even when providing a similar amount of
therapeutic power; they generally offer well-defined and precise
control over wavelength and power; they generally allow for control
of the pattern of illumination by allowing the placement of
discrete optical emitters over a complex surface area and by
allowing for individual control of each emitter; they also
generally allow for easy integration with other microelectronic
sensors (e.g., photodiodes) to achieve low cost integrated
components; and finally, solid state components generally permit
placement of the light source close to the treatment site rather
than relying on costly, inefficient, and unstable optical guidance
systems and light sources to do so. Solid state technology also
promises portability and patient convenience (e.g., better patient
compliance) because the lower cost and improved safety profile of
the devices will allow for transfer of the therapies from the
physician office and hospital to the patient's home.
[0080] Solid state lighting technology has recently advanced to the
point where it is useful in the longer wavelength ultraviolet and
even more recently in the short ultraviolet wavelengths. For
example, S-ET (Columbia, S.C.) manufactures LED dies as well as
fully packaged solid state LEDs that emit relatively monochromatic
ultraviolet radiation from 240 nm to 365 nm. Similarly, Nichia
Corporation (Detroit, Mich.) supplies ultraviolet light emitting
diodes which emit relatively monochromatic, non-coherent light in
the range 365 nm to 400 nm. White light emitting diodes have been
available for a relatively long time and at power densities which
rival conventional lighting sources. For example, the LED Light
Corporation (Carson City, Nev.) sells high powered white light LEDs
with output from 390 nm to 600 nm. Cree Inc. (Durham, N.C.) also
produces and sells LED chips in the long wave ultraviolet as well
as the blue, amber and red portions of the electromagnetic
spectra.
[0081] Although some embodiments of the present invention include
solid state light sources, other embodiment include non-solid state
technologies, such as low pressure lamps, with or without solid
state light sources. The Jelight Corporation (Irvine, Calif.)
provides customized low pressure mercury vapor lamps complete with
phosphors which emit a relatively narrow spectrum depending on the
phosphor used. For example, Jelight's 2021 product emits 5 mW in
the 305 nm to 310 nm portion of the electromagnetic spectrum.
[0082] Halogen lighting technology can also be used to generate
ultraviolet light, including light having wavelengths in the UVA
(e.g., 320-400 nm), UVB (e.g., 280-320 nm), and white light (e.g.,
400-700 nm) portions of the spectrum, as well as relatively
narrow-band ultraviolet light (for example, when the lamp is
provided with an appropriate filter and/or phosphors). For example,
Gilway Technical Lamp (Wolburn, Mass.) supplies quartz halogen
lamps, which are enhanced for ultraviolet emission by virtue of the
quartz (rather than ultraviolet absorbing glass) bulb covering the
filament. Such lamps are generally inexpensive, small, generate
minimal heat, and may therefore be incorporated with many of the
embodiments of the present invention, as disclosed in greater
detail below.
[0083] In many embodiments of the present invention, novel methods
and devices to treat diseases utilizing optical therapies are
disclosed. In addition to novel disease treatments and methods,
many embodiments of the present invention are portable, and may be
implemented with many of a variety of light sources. In many
embodiments, a specific desired illumination pattern and
controlling a preferred spectral output may be achieved.
[0084] An optical therapy device 100 in accordance with one
embodiment of the present invention is illustrated in FIG. 1. The
optical therapy device 100 generally includes a body and a light
source 126. The term "body" is intended to have its ordinary
meaning and can mean any structure of any size or configuration. In
one embodiment, the body refers to the optical therapy device 100
without the light source 126 and without the external power supply
110 or power cords 114 connected. The body of the optical therapy
device in combination with the light source 126 can be held in
one's hand or hands for an extended period of time (e.g., a
therapeutic time) without undue effort or discomfort. The body and
the light source 126 together can also be held in one's hand or
hands and applied to the nasal cavity of a patient without undue
effort or discomfort. In one embodiment, where the device is
applied to the patient's nasal cavity, the body is not longer than
about 30 cm. In another embodiment where the device is applied to
the patient's nasal cavity, the body is not longer than about 50
cm. In another embodiment where the device is applied to the
patient's nasal cavity, the body is not longer than about 20 cm.
The body and the light source 126 should be able to fit into a
typically sized briefcase or overnight bag.
[0085] The body and light source in some embodiments do not weigh
more than about one pound. In other embodiments, the light source
and body do not weigh more than about two pounds. And in still
other embodiments, the body and light source do not weigh more than
about three pounds. When a cord 114 is attached, the device and
computer 110 are attached (e.g., the optical therapy system), the
body and light source continue to be held in one's hand or hands.
Optical therapy device 100 can have a handpiece 102 that in one
embodiment has a contoured surface for right-handed or left-handed
gripping by a user. The distal end 104 of the handpiece 102 can be
coupled to a tube 106 at the tube's proximal end 108; in one
embodiment, the tube 106 is adapted to transport light. The
proximal end 112 of the handpiece 102 can also be coupled to a
power supply 110. A power coupling 114 can couple the handpiece 102
to the power supply 110.
[0086] The tube 106 is, in one embodiment generally shaped and
sized to be inserted through the nostril of a patient and into the
patient's nasal cavity. The nasal cavity is used herein to refer to
the region of the nose from the nares to the nasopharynx and
includes the paranasal sinuses and the nasal septum. For insertion
into the nostril of a patient, the diameter of the distal end of
the device body 116 is generally not larger than about 1 cm. In
some embodiments, the diameter of the distal end of the device body
116 is not larger than about 5 mm. In other embodiments, the
diameter of the distal end of the device body 116 is not larger
than about 3 mm. In one embodiment, the tube 106 has a tapered
shape, and tapers from a large diameter at its proximal end 108 to
a smaller diameter (e.g., about 1 cm) at its distal end 116. The
diameter at the proximal end 108 can be chosen for the ergonomic
comfort of the person holding the device. In some embodiments, the
diameter of the proximal end 108 is in the range of from about 1 cm
to about 5 cm. The proximal end can also be contoured as a hand
grip for a right or left-handed user. The distal end 116 has
additional features which can control the illumination pattern.
Additional features and embodiments of the tube 106 and its distal
end 116 are provided in greater detail below.
[0087] In one embodiment, the tube 106 includes a tip 118 at the
distal end 116 of the tube 106. The tip 118 of the tube 106 is any
of a variety of optically transparent or partially transparent
structures. The term "optically transparent" is intended to have
its ordinary meaning, and to also mean transparent to wavelengths
between about 250 nm and about 800 nm. In some cases, optically
transparent can refer to more narrow ranges of transparency. For
example, "optically transparent to ultraviolet light" can refer to
transparency in the range from about 200 nm to 400 nm; "optically
transparent to ultraviolet B" can refer to transparency in the
range from about 280 nm to about 320 nm.
[0088] In one embodiment, the tip 118 includes a window, a
diffusing lens, a focusing lens, an optical filter, or a
combination of one or more of such tip types or other tip types
which allow the spectral output to be conditioned. The terms
conditioning, conditioner, and the like refer to their ordinary
meaning, as well as a modification of the spectral output or the
geometric illumination pattern of the device. In one embodiment, to
provide a desired output spectrum, three types of tips are used in
series within the tube 106. For example, in one embodiment, a lens
is used to diffuse (e.g., refract) certain wavelengths while
filtering (e.g., transmitting certain wavelengths and absorbing
others) certain wavelengths, and serving as a window (e.g.,
transmitting) certain wavelengths. In another embodiment, the light
from the tube 106 is transferred through tip 118 through a series
of internal reflections. In one embodiment, the tip 118 is made at
least in part from a different material than that of the tube 106.
The tip 118 of the tube 106 may be shaped or designed to disperse
light as it exits the reflecting tube 106 and is transmitted to a
patient.
[0089] In some embodiments, tube 106 can be a reflecting tube and
can be manufactured from any of a variety of materials, including
plastic, stainless steel, nickel titanium, glass, quartz, aluminum,
rubber, lucite, or any other suitable material known to those of
skill in the art that may be adapted to be place inside of a
patient's body. In some embodiments, the material of the tube is
chosen to reflect certain wavelengths and/or absorb others. In some
embodiments, the tube is configured to yield near or total internal
reflection.
[0090] In one embodiment, the reflecting tube 106 is hollow. The
inside wall 120 of the reflecting tube 106 at least partially
reflects light of a selected wavelength. The inside wall 120 may
include a reflecting layer 122 applied over its entire surface
although in other embodiments the inside wall 120 does not include
a reflecting layer 122. In one embodiment, the reflective layer 122
includes a coating of a reflecting material such as, for example,
aluminum, silica carbide, or other suitably reflective
material.
[0091] The proximal end 108 of the tube 106 is coupled to the
distal end 105 of the handpiece 102 by any of a variety of
couplings 124 well known to those of skill in the art. For example,
in one embodiment, the coupling 124 includes a press-fit
connection, a threaded connection, a weld, a quick-connect, a
screw, an adhesive, or any other suitable coupling as is known to
those of skill in the art. Coupling 124 includes mechanical,
optical, and electrical couplings, as well as combinations
thereof.
[0092] In one embodiment, the coupling 124 is releasable so that
the tube 106 may be decoupled or removed from the handpiece 102.
Such coupling 124 may also be made from a disposable material. In
another embodiment, the reflecting tube 106 is permanently attached
to the handpiece 102. In such case, the coupling 124 is a permanent
connection.
[0093] In one embodiment, the handpiece 102 of the body includes a
light source 126. The light source may be any of a variety of high,
low, or medium pressure light emitting devices such as for example,
a bulb, an emitter, a light emitting diode (LED), a xenon lamp, a
quartz halogen lamp, a standard halogen lamp, a tungsten filament
lamp, or a double bore capillary. tube, such as a mercury vapor
lamp with or without a phosphor coating. The particular light
source selected will vary depending upon the desired optical
spectrum and the desired clinical results, as will be described in
greater detail below. Although the light source 126 of FIG. 1 is
shown in the handpiece 102, the light source 126 can be placed
anywhere on, in, or along the optical therapy device 100. In some
of the embodiments discussed below, multiple light sources are
placed within the optical therapy device 100, some of which may
reside in the handpiece 102 and some of which may reside on or in
the tube 106, and some of which may reside on or in the tip
118.
[0094] In one embodiment, the light source 126 includes a
phosphor-coated, low pressure mercury vapor lamp. In a related
embodiment, the phosphor is placed distal to the mercury vapor
lamp; for example, the phosphor is coated onto the reflecting tube
106 or is incorporated into the tip 118. Optical emitter 128
illustrates the light emitting portion of the light source 126. In
one embodiment, optical emitter 128 is a filament. Such filaments
may be used when light source 126 is an incandescent or halogen
lamp. When light source 126 is a mercury vapor lamp, optical
emitter 128 can be an inner capillary tube where the mercury plasma
emits photons. Leads 132 extending from the light source 126,
electrically couple the light source 126 with a control circuit
134. In one embodiment, the control circuit 134 is in electrical
communication with a controller 136 and with power supply 110 via
the power coupling 114.
[0095] In some embodiments, it is desired to control variables or
control parameters associated with the output of the optical
therapy device 100. Examples of such variables include power,
timing, frequency, duty cycle, spectral output, and illumination
pattern. In one embodiment, the control circuit 134 controls the
delivery of power from the power supply 110 to the light source 126
according to the activation or status of the controller 136. For
example, in one embodiment, the control circuit 134 includes a
relay, or a transistor, and the controller 136 includes a button,
or a switch. When the button or switch of the controller 136 is
pressed or activated, power from the power supply 110 is able to
flow through the control circuit 134 to the light source 126.
[0096] The variables can be controlled in response to, for example,
at least one photoreflectance parameter, which, for example, may be
measured or obtained at the distal end 116 of the therapy device
100. Other variables or control parameters include a desired
dosage, or a previous dosage. In some embodiments, the patient or
treating physician can adjust the treatment time based on the prior
history with the optical therapy device 100. In some embodiments,
controller mechanisms, which can be integral to the optical therapy
device 100, allow for control over dosage and illumination. In
other embodiments, the controller tracks the total dose delivered
to a patient over a period of time (e.g., days to months to years)
and can prohibit the device from delivering additional doses after
the preset dosage is achieved.
[0097] Although the control circuit 134 is illustrated within the
handpiece 102 of the optical therapy device 100, in another
embodiment, the control circuit 134 is located within the power
supply 110. In such embodiments, the controller 136 communicates
with the control circuit 134 through the power coupling 114.
Control data, commands, or other information may be provided
between the power supply 110 and the handpiece 102 as desired. In
one embodiment, control circuit 134 stores information and data,
and can be coupled with another computer or computing device.
[0098] In one embodiment, power from the power supply 110 flows to
the control circuit 134 of the handpiece 102 through a power
coupling 114. The power coupling 114 maybe any of a variety of
devices known to those of skill in the art suitable for providing
electrical communication between two components. For example, in
one embodiment, the power coupling 114 includes a wire, a radio
frequency (RF) link, or a cable.
[0099] The light source 126 is generally adapted to emit light with
at least some wavelengths in the ultraviolet spectrum, including
the portions of the ultraviolet spectrum known to those of skill in
the art as the UVA (or UV-A), UVA1, UVA2, the UVB (or UV-B) and the
UVC (or UV-C) portions. In another embodiment of the current
invention, light source 126 emits light in the visible spectrum in
combination with ultraviolet light or by itself. Finally, in yet
another embodiment, the light source 126 emits light within the
infrared spectrum, in combination with white light and/or
ultraviolet light, or by itself. Light source 126 may be adapted to
emit light in more than one spectrum simultaneously (with various
phosphors, for example) or a multiplicity of light sources may be
provided to generate more than one spectrum simultaneously. For
example, in one embodiment, the light source 126 emits light in the
UVA, UVB, and visible spectra. Light emission at these spectra can
be characterized as broad- or narrow-band emission. In one
embodiment, narrow-band is over a bandgap of about 10-20 nm and
broad-band is over a band gap of about 20-50 nm.
[0100] In other embodiments, the spectrum is continuous. Continuous
(or substantially continuous) emission is intended to have its
ordinary meaning, and also to refer to generally smooth uniform
optical output from about 320-400 nm for UVA, 280-320 nm for UVB,
and below about 280 nm for UVC. In other embodiments, the light
source 126 emits light in any two of the foregoing spectra and/or
spectra portions. In addition, in some embodiments, some portions
of the spectra are smooth and others are continuous.
[0101] For example, in one embodiment, the light source 126 emits
light having a narrow-band wavelength of approximately 308 nm
within the UVB portion of the UV spectrum. In another embodiment,
the light source 126 emits light having a wavelength below
approximately 300 nm. In other embodiments, the light source 126
emits light having a wavelength between about 254 nm and about 313
nm.
[0102] In one embodiment, the optical therapy device 100 includes
more than one light source 126, where each light source 126 has an
output centered at a different wavelength. Each light source 126
can have an output that can be characterized as broad-band,
narrow-band, or substantially single band. All light sources 126
can be the same characterization, or may have one or more different
characterizations. For example, in one embodiment, the optical
therapy device 100 includes three light sources 126: one that emits
light in the UVA region of the UV spectrum, one that emits light in
the UVB region of the UV spectrum, and one that emits light in the
visible region of the optical spectrum.
[0103] The light sources may each emit light at a different energy
or optical power level, or at the same level. The optical therapy
device 100 may be configured to provide light from three light
sources 126, each having a different relative output energy and/or
relative energy density level (e.g., fluence). For example, in one
embodiment, the optical energy emitted from the light source 126
that provides light in the UVA region of the UV spectrum is about
10%, 20%, 25%, 35%, between about 15% and about 35%, or at least
about 20% of the optical energy and/or fluence provided by the
optical therapy device 100. In one embodiment, the optical energy
emitted from the light source 126 that provides light in the UVB
region of the UV spectrum is about 1%, 3%, 5%, 8%, 10%, between
about 1% and about 11%, or at least about 2% of the optical energy
and/or fluence provided by the optical therapy device 100. In one
embodiment, the optical energy emitted from the light source 126
that provides light in the visible region of the optical spectrum
is about 50%, 60%, 75%, 85%, between about 60% and about 90%, or at
least about 65% of the optical energy and/or fluence provided by
the optical therapy device 100.
[0104] In one embodiment, the optical therapy device 100 includes a
UVA light source 126, a UVB light source 126, and a visible light
source 126, where the UVA light source 126 provides about 25%, the
UVB light source provides about 5%, and the visible light source
provides about 70% of the optical energy and/or fluence provided by
the optical therapy device 100. For example, in one embodiment, the
optical therapy device 100 provides a dose to the surface it is
illuminating (e.g., the nasal mucosa) of about 2 J/cm2, where the
UVA light source 126 provides about 0.5 J/cm2, the UVB light source
126 provides about 0.1 J/cm2, and the visible light source 126
provides about 1.4 J/cm2. In another embodiment, the optical
therapy device 100 provides a dose of about 4 J/cm2, where the UVA
light source 126 provides about 1 J/cm2, the UVB light source 126
provides about 0.2 J/cm2, and the visible light source 126 provides
about 2.8 J/cm2. In another embodiment, the optical therapy device
100 provides a dose of about 6 J/cm2, where the UVA light source
126 provides about 1.5 J/cm2, the UVB light source 126 provides
about 0.3 J/cm2, and the visible light source 126 provides about
4.2 J/cm2. In yet another embodiment, the optical therapy device
100 provides a dose of about 8 J/cm2, where the UVA light source
126 provides about 2 J/cm2, the UVB light source 126 provides about
0.4 J/cm2, and the visible light source 126 provides about 5.6
J/cm2. In some embodiments, the white light is omitted from the
therapy leaving only the doses of the ultraviolet light. In some
embodiments, the white light and the UVA are omitted leaving only
the UVB doses. In other embodiments, the UVB and the white light
are omitted leaving only the UVA dose. In other embodiments the UVB
dosage is concentrated in the range from 305 nm to 320 nm,
sometimes referred to as UVB 1. UVB 1 can be used in place of UVB
in any of the combinations and doses above. In other embodiments,
UVA1 (e.g., 340-400 nm) is used in any of the embodiments above in
place of UVA. In yet other embodiments, UVA2 (e.g., 320-340 nm) is
used in the embodiments above in place of UVA. In some embodiments,
blue light (e.g., 400-450 nm) or a combination of blue light and
long wavelength UVA (e.g., 375-450 nm) is used to treat tissue. In
some embodiments, the dose of blue light or combination UVA-blue
light is about 20-100 times greater than UVB. In some embodiments,
the fluence in the above measurements represents energy delivered
to a body cavity. For example, when the body cavity is the nasal
cavity, the area over which the light is delivered can be
approximately 5-30 cm2; therefore the energy in each region of the
optical spectrum leaving the optical therapy device is in some
embodiments 5-30 times the energy reaching the surface of the body
cavity.
[0105] In some embodiments, a ratio is defined between the
wavelengths. In one embodiment, the ratio between the total UVA
power and the total UVB power (the power ratio) is about 5:1. In
other embodiments, the ratio is between 5 and 10:1. In other
embodiments, the ratio is between 10 and 15:1. In some embodiments,
UVB 1 is substituted in the defined ratios. In any of the above
ratios, visible light can be excluded or included. In some
embodiments, the power ratio is further defined between UVA 1 and
UVB 1; for example, the power ratio can be from 40: 1 to 80:1 for a
ration of UVA 1 to UVB 1.
[0106] Optical energy densities are generally derived from a power
density applied over a period of time. Various energy densities are
desired depending on the disorder being treated and may also depend
on the light source used to achieve the optical output. For
example, in some embodiments, the energy densities are achieved
over a period of time of about 0.5 to 3 minutes, or from about 0.1
to 1 minute, or from about 2 to 5 minutes. In some embodiments, for
example, when a laser light source is used, the time for achieving
these energy density outputs may be from about 0.1 seconds to about
10 seconds. Certain components of the optical spectrum can be
applied for different times, powers, or energies. In the case where
multiple light sources are used, one or more light sources can be
turned off after its energy density is provided or achieved.
[0107] Energy density or fluence or other dosage parameter, such
as, for example, power, energy, illumination, or irradiance, may be
measured at any of a variety of positions with respect to the tip
118 of the optical therapy device 100. For example, in one
embodiment, fluence is measured substantially at the tip 118 of the
optical therapy device 100. In this case, the dosage at the
illumination surface is the fluence multiplied by the fluence area
(for total power) and then divided by the illuminated surface area
(e.g., in the nasal cavity, the surface area can range between 5
and 25 cm2). Therefore to achieve the desired dosage density, the
fluence at the tip is approximately the dosage multiplied by
illuminated surface area and then divided by the tip area. In
another embodiment, the fluence is measured at a distance of about
0.5 cm, about 1 cm, or about 2 cm from the surface of the tip 118
of the optical therapy device 100.
[0108] The particular clinical application and/or body cavity being
treated may determine the energy density or dosage requirements. If
the lining of the cavity is particularly far away from the optical
therapy device 100, a higher energy, fluence, or intensity may be
chosen. In the case where the nasal cavity is being treated and
rhinitis is the disease, the dosage from the tip 118 may be chosen
appropriately. For example, it has been shown by in-vitro work that
T-cells undergo apoptosis at energy densities of about 50-100
mJ/cm2 of combined UVA, UVB, and white light. The energy densities
exiting from the tip of the optical therapy device used to achieve
such energy densities as measured at the mucosa, or treatment site,
may be 5-10 times this amount because of the optical therapy
distance 100 from the nasal mucosa cells during treatment.
[0109] The energy densities may be further increased from that
achieved in-vitro because of intervening biologic materials that
may absorb light. For example, the mucus, which is present on top
of the nasal mucosa in all patients, may absorb light in the
desired region of the spectrum. In this case, the fluence or output
of the optical therapy device 100 at the tip 118 can be corrected
for the extra absorption. Furthermore, the mucosa may absorb more
or less light at different time points during an allergy season
(for example) and therefore the fluence of the optical therapy
device may be controlled at these times. In many embodiments, this
control is provided by the optical therapy devices.
Photoreflectance data from the mucosa can be used by the patient,
the medical practitioner, or automatic feedback (e.g., from the tip
118) to a controller and/or data processor. Such data can be used
to estimate the thickness of the mucus layer and adjust the output
of the optical therapy device 100 accordingly. In addition, the
practitioner can evaluate the mucosa visually with a rhinoscope and
adjust the optical parameters accordingly; in another embodiment,
tube 106 delivers an image from the region surrounding the distal
tip 118.
[0110] The dosage may be measured at a planar or curved surface
with respect to the tip 118 of the optical therapy device 100. For
example, in one embodiment, the dosage is measured at a plane that
is tangential to the surface of the tip 118 of the optical therapy
device 100. In another embodiment, the dosage is measured at a
plane that is a distance of about 0.5 cm, 1 cm, 2 cm, 3 cm or 5 cm
from the surface of the tip 118 of the optical therapy device 100.
In another embodiment, the dosage is measured at a partially
spherical plane that is at least partially tangential to, or at a
distance of about 0.5 cm, 1 cm, 2 cm, 3 cm or 5 cm from the surface
of the tip 118 of the optical therapy device 100. The selection of
planar or curved surface for dosage measurement, and the distance
between the measurement plane and the optical therapy device 100
tip 118 may be selected based upon the particular geometry of tip
118 utilized.
[0111] In one embodiment, the output portion 130 of the light
source 126 is positioned so that it resides within at least a
portion of the tube 106. When the output portion 130 of the light
source 126 is so positioned, light emitted from the light source
126 is transmitted directly into the tube 106. In this embodiment,
the tube is a reflecting tube. In such a case, optical losses may
be minimized, or reduced. In addition, by positioning the output
portion 130 of the light source 126 inside of the tube 106,
additional optical focusing elements, such as lenses or mirrors,
may not be required; moreover, the geometry of the tube can be
optimized, such that light conduction is optimized by for example,
creating surfaces within the tube designed to reflect light through
and along the tube to transport the light to the distal end of the
tube. In addition, the tube can be created to optimize total
internal reflection of the light from the light source.
[0112] In some embodiments, the optical reflectance tube 120
includes one or more optical fibers that capture and guide the
light from the light source/s 126. When the light sources 126 are
small semiconductor structures, the fibers can encapsulate the
semiconductor structure and faithfully transmit substantially all
of the light from the light source 126. More than one fiber can be
used to direct the light from multiple light sources 126. For
example, each fiber can transmit light from one light source 126.
In other embodiments, the optical tube 106 is or includes a light
guide such as a liquid light guide (e.g., such as those available
from EXFO in Ontario, CA).
[0113] The tube 106 may taper from a large diameter at its proximal
end 108 to a smaller diameter at its distal end 116, in which case
the tube 106 has a larger diameter at its proximal end 108 than at
its distal end 116. In another embodiment, the tube 106 may taper
from a larger diameter at its distal end 116 to a smaller diameter
at its proximal end 108. In such case, the tube 106 has a larger
diameter at its distal end 116 than at its proximal end 108. In
other embodiments, the tube 106 is substantially cylindrical. In
such case, the diameter of the tube 106 may be substantially
constant along its entire length.
[0114] In one embodiment, the tube 106 is flexible so that its
shape and orientation with respect to the handpiece 102 may be
adjusted. A flexible material, such as rubber, plastic, or metal
may be used to construct the tube 106, and to provide flexibility
thereto. In one embodiment, a goose-neck tube, or spiral wound coil
is used to provide a flexible tube 106. In such embodiments, an
outer sheath 142 may be provided with the tube 106 to isolate the
flexible portion of the tube 106 from the inside of a patient's
nasal cavity.
[0115] An outer sheath 142 can be made from any of a variety of
biocompatible materials well-known in the art such as, but not
limited to, PTFE, ePTFE, FEP, PVDF, or silicone elastomers. The
outer sheath can be disposable so that a clean, sterilized sheath
can be used for each newly treated patient. The outer sheath 142
can also have beneficial optical properties. For example, the outer
sheath can diffuse or otherwise pattern the light entering it from
the optical tube 106. The outer sheath can be made of more than one
material. For example, in some embodiments, the portion of the
sheath where the light exits (e.g., the lens) 140 can be produced
from an optically transparent material such as silicone, fused
silica, or quartz, and the biocompatible portion which surrounds
tube 106 can be produced from a material which is more flexible or
lubricious, such as PTFE, but which does not necessarily transmit
ultraviolet light.
[0116] In one embodiment, tube 106 is sized so it may be inserted
into the nasal cavity of a patient or user as discussed above. In
one embodiment, the tube 106 is inserted into the nasal cavity
until its tip 118 reaches the turbinates, the sinuses, or the ostia
to the sinuses. The tube 106 may be made of flexible materials so
that it can bend, or be steered around corners, or conform to the
shape of the nasal cavity, as required. In other embodiments, the
light is emitted from just beyond the nares and diffuses along a
cylindrical path toward the nasal mucosa.
[0117] The tube 106 may be made from any one or a combination of
materials as described above. For example, the tube 106 may be made
from polymers. In such case, since many polymers absorb light in
the ultraviolet portion of the spectrum, the inside wall 120 of the
tube 106 may be coated with a reflective coating or layer 122, as
described above. The outside of the tube 106 can also be coated
with a polymer with the inner material being one of the materials
noted above.
[0118] In one embodiment, the reflective layer 122 includes an
electrolessly-deposited metal. For example, layer 122 may include
nickel, nickel-phosphorous, cobalt, cobalt-phosphorous,
nickel-cobalt-phosphorous and/or a noble metal. In other
embodiments, the layer 122 includes a reflective polymeric coating.
In other embodiments, the reflecting layer is a specialty thin
film, such as silica carbide deposited in a chemical vapor
deposition process.
[0119] In one embodiment, the tube 106 includes quartz, fused
silica, aluminum, stainless steel, or any material which reflects a
substantial amount of light in the ultraviolet region and/or
visible region of the electromagnetic spectrum.
[0120] The optical therapy device 100 generally allows for the use
of low pressure light sources 126 and can be manufactured at low
cost using safe light sources 126. By utilizing a low pressure
light source 126, the light source 126 may be manufactured at a
small size so that it can fit within a hand-held handpiece 102 of
the optical therapy device 100.
[0121] The controller 136 of the optical therapy device 100 is
adapted to control the quantity (e.g., total energy) and intensity
(e.g., power) of light emitted by the light source 126 and thereby
exiting the tip 118 of the optical therapy device 100. For example,
in one embodiment, the controller 136 determines and/or controls
the power from the power supply 110 as described in greater detail
above. In one embodiment, the controller 136 may be programmed and
may include a timer so that only a pre-specified amount of light
can be provided by the optical therapy device 100 at any given
time, and such that a user cannot receive more than a predetermined
dose in a specified short time period (e.g., over a period of one
day) or a number of doses in a specified time period (e.g., over a
period of months, for example). In other embodiments, the
controller 136 determines the illumination pattern. For example, by
turning one or more light sources on and off, the illumination
pattern can be controlled. The controller 136 can further control
the illumination pattern by moving (actively or passively) or
otherwise altering the aperture or pattern of the tip 118. The
controller 136 can also apply current to the light sources at a
desired frequency or duty cycle.
[0122] In another embodiment, the controller 136 delivers a large
current or a current or voltage pulse to the light source 126 to
"burn out" or destroy the light source 126 after a selected period
of time. For example, after a predetermined "useful lifetime" of
the optical therapy device 100 expires, a "burn out" current is
provided and the optical therapy device 100 essentially ceases to
function. At this time, the optical therapy device 100 is
discarded. The controller 136 can also respond to or receive a
control signal from one or more photodetectors placed in or on the
tube 106 or the controller can respond to receive a control signal
from one or more photodetector devices in an external calibration
unit.
[0123] The power supply 110 of the optical therapy device 100 is
adapted to receive power from an alternating current (AC) source, a
direct current (DC) source, or both depending on the number and
types of light sources. For example, in one embodiment, power
supply 110 includes a battery, battery pack, rechargeable DC
source, capacitor, or any other energy storage or generation (for
example, a fuel cell or photovoltaic cell) device known to those of
skill in the art. In some embodiments, an LED may utilize a DC
power source whereas a mercury vapor lamp may utilize an AC power
source.
[0124] In one embodiment, the light source 126 includes a low
pressure lamp with an output (measured at any of the locations
described above) between about 100 .quadrature.W/cm2 and about 5
mW/cm2. In one embodiment, the light source 126 generates
ultraviolet light and it includes at least a small amount of
mercury within a nitrogen atmosphere. As discussed above, the
output portion 130 of the light source 126 may be any material
translucent to ultraviolet light, such as, for example, but not
limited to, quartz, silicone or fused silica. The output portion
can direct the light in a uniform or non-uniform pattern.
[0125] In one embodiment, when mercury vapor is used in connection
with the light source 126, the light source 126 provides
ultraviolet light having an output peak concentrated at 254 nm. In
another embodiment, a phosphor or a combination of phosphors can be
used, as is widely known to those skilled in the art. In one
embodiment, phosphors are added to the light source 126 such that
the output peaks from the light source 126 are customized based
upon the desired clinical application and action spectra for the
disease process being treated. In one embodiment, the light source
126 includes a mercury vapor lamp having a spectral output which
resides in longer wavelengths of the ultraviolet spectrum and in
some embodiments extends into the visible spectrum.
[0126] In one embodiment, light source 126 is a mercury vapor lamp
such as the type 2095 lamp manufactured by Gelight Corporation. In
another embodiment, the light source 126 includes a light emitting
diode (LED) such as the UV LED manufactured by S-ET Corporation
(Columbia, S.C.), which can be produced to emit narrowband light at
any wavelength from about 250 nm to 365 nm. In another embodiment,
the light source 126 emits at a wavelength of 275 nm. In such
cases, the UV LED may have a sapphire substrate with conductive
layers of aluminum gallium nitrite. For example, in one embodiment,
the UV LED has about 50% aluminum. By varying the concentration of
aluminum, the wavelength peak can be adjusted. In some embodiments,
the several LEDs are packaged together such that light output with
multiple peaks in the ultraviolet range can be achieved. In some
embodiments, the aluminum concentration is varied along a dimension
of the chip such that a more continuous spectrum is achieved when
current is passed through the chip. In addition, the UV LED
packaging may include flip-chip geometry. In such case, the LED die
is flipped upside down and bonded onto a thermally conducting
sub-mount. The finished LED is a bottom-emitting device that may
use a transparent buffer layer and substrate.
[0127] In such embodiments, the light is two-times brighter when
the LEDs are in a flip-chip geometry. This is due to the fact that
light emitted from the LED is not physically blocked by an opaque
metal contact on the top of the LED. In addition, flip-chip
sub-mount pulls heat away from the device when made from materials
having high thermal conductivity. This improves efficiency levels
with less energy being converted to heat and more energy being
converted to light. The resulting device will have a lower weight,
will be smaller, and will be resistant to vibrations and shock.
[0128] In other embodiments, power delivery to the LEDs can be
modified to optimize the optical power of the LEDs. In such cases,
the LEDs are switched on and off in order to prevent heat build up
which would otherwise decreases the efficiency of the LEDs. For
example, a temperature rise may decrease the potential optical
power. Such switching can increase the power output several-fold.
In other embodiments, the semiconductor structure takes the form of
a laser diode module wherein the semiconductor package contains
reflecting optics to turn the non-coherent light into coherent
light.
[0129] Although the power supply 110 of the optical therapy device
100 is illustrated in FIG. 1 as tethered to the proximal end 112 of
the handpiece 102, it should be well understood by those of skill
in the art that the power supply 110 may be incorporated into or
included on or within the body of the device, including the
handpiece 102. In such cases, the power supply 110 may include a
battery, a battery pack, a capacitor, or any other power source.
The power coupling 114 in such embodiments may include contacts or
wires providing electrical communication between the power supply
110 and the control circuit 134.
[0130] A sleeve 140 may be provided to at least partially cover the
tube 106. In one embodiment, the sleeve 140 is disposable and in
another embodiment, the sleeve is not disposable. The term
"disposable" is intended to have its ordinary meaning. In addition,
as is known to those skilled in the art, disposable can also refer
less to the particular material used and more to the cost of
production and sales price of a component, as well as the procedure
required to sterilize or otherwise clean the component between
uses.
[0131] In some embodiments, the sleeve is sterilizable and in other
embodiments, the sleeve is not sterilizable. Sterilizing methods
include, without limitation, ethylene oxide (ETO), autoclaving,
soap and water, acetone, and alcohol. In some embodiments, the
sheath is machined and in other embodiments, the sleeve is formed
from a mold. In still further embodiments, the sleeve is produced
from a thermoforming process. In some embodiments, the sleeve is
composed of multiple materials. For example, the body of the sleeve
is produced from a material such as aluminum or a plastic coated
with aluminum and the end of the sleeve is an optically transparent
material. The end of the sleeve can also have an open configuration
where the light diverges as it leaves the sleeve. The sleeve can
also be solid and produced from the same or different materials. In
this embodiment, the inner material will transmit light without
absorbing the light. These configurations generally allow optical
energy, or light, generated by the light source 126 to travel
through the tube 106 and exit both the tip 118 of the tube 106 and
the tip 140 of the sleeve. In such embodiments, light energy is
emitted from the optical therapy device 100 and absorbed by the
tissue within the body cavity (e.g., nasal cavity of the patient's
nose).
[0132] The optical emitter 128 of the light source 126 is generally
in electrical communication with leads 132. In one embodiment, the
optical emitter 128 extends in a direction transverse the axis of
the light source 126. As discussed above, the optical emitter 128
schematically represents only one embodiment of the light emitting
portion of the handpiece 102 and light source 126. Optical emitter
128 (e.g., the light emitting portion of the light source 126) can
be made from any of a variety of materials known to those of skill
in the art; in cases where the optical emitter 128 represents a
wire-filament type light source, the optical emitter 128 can
include tungsten.
[0133] In embodiments where the light source 126 includes a
gas-filled tube, such gases may include xenon, helium, argon,
mercury, or mercury vapor, or a combination thereof, in order to
produce a desired spectral output.
[0134] Although the optical emitter 128 of the light source 126 is
shown at the distal end 124 of the handpiece 102, in other
embodiments, the optical emitter 128 is positioned closer to the
proximal end 112 of the handpiece 102. By moving the optical
emitter 128 proximal with respect to the tip 118 of the tube 106,
heat generated by the light source 126 may be at least partially
separated from the tube 106, thereby lessening thermal
communication with the patient's tissues.
[0135] Heat generated by the light source 126 may be removed from
the optical therapy device 100 by any of a variety of methods and
devices known to those of skill in the art. For example, in one
embodiment, heat is directed away from the handpiece 102 by
convection or conduction. In other embodiments, active cooling
devices, such as thermo-electric coolers or fans may be employed.
Alternatively, or in addition, passive cooling structures, such as
heat fins, heat conductors and/or cooling tubes may be used to
remove heat from the optical therapy device 100.
[0136] In one embodiment, the light source 126 includes a solid
state light emitter (e.g., an LED or laser diode module) and the
light source 126 is positioned at or near the distal end 116 of the
tube 106 instead of within the handpiece 102.
[0137] In another embodiment, the light source 126 includes a solid
state emitter and a mercury vapor lamp (or other analog-type light
source that emits ultraviolet light as described above). Such
combinations may be useful to provide light of multiple wavelengths
or intensities that correspond to select spectral peaks. In another
embodiment, multiple solid state emitters may be employed to
achieve the same or similar results. In yet another embodiment, a
visible light solid state emitter is combined with a mercury vapor
or halogen lamp to enhance wavelengths in the visible light region.
Alternatively, an array of solid state emitters may be arranged on
an integrated circuit layout to produce spectral output that can be
continuous or semi-continuous depending upon the wavelength, number
and bandwidth of each emitter.
[0138] The tube 106 may include a soft coating on its outside
surface 138. A soft coating, such as a polymer, rubber, or
fluid-filled jacket, provides a comfortable interface between the
outside surface 138 of the reflecting tube 106 and the patient's
nose.
[0139] In addition, the reflecting tube 106 may include one or more
filters along its length. In one embodiment, a filter is placed
inside the reflecting tube 106 near its proximal end 112 or near
its distal end 116. The filter may function as a lens if cut into
an appropriate shape and placed at the distal end 116 of the
reflecting tube 106. One such optical filter well known to those of
skill in the art is manufactured by Schott and includes glass
optimized for absorption at certain wavelengths.
[0140] In one embodiment, the light source 126 is about 10% to
about 15% efficient. In another embodiment, the light source or
combinations of light sources 126 generates about 10 mW to about
100 mW of optical power. In another embodiment, the light source
dissipates between about 10 W to about 20 W of power in order to
generate about 10 mW to about 100 mW of optical power. In one
embodiment, excess heat is dissipated so that the optical therapy
device 100 does not overheat, and/or so that the patient does not
experience discomfort during its use.
[0141] Heat transfer control may become increasingly important when
the optical therapy device 100 includes a light source 126 that is
located near the distal end 116 of the tube 106 (e.g., heat may be
closer to the patient's tissue). In one embodiment where the light
source 126 is a mercury vapor light source, heat is generated near
the output portion 130, for example, where the mercury plasma is
generated. Since, in this embodiment, most of the light generated
is non-blackbody radiation, very little heat is generated as
photons propagate towards the distal end 116 of the tube 106 and
enter the tissue of the patient. Therefore, in such embodiments,
heat transfer mechanisms are generally confined to the output
portion 130 of the light source 126, close to where the light is
generated.
[0142] In one embodiment, a fan is used to transfer heat or to
remove heat from the optical therapy device 100. For example, the
fan may surround the output portion 130 of the light source 126 or
the entire light source 126 itself In such embodiments, the fan may
surround the light source 126, or a portion thereof, in an annular
fashion, and can direct heat away from the light source 126 and
away from the patient via convection.
[0143] In another embodiment, a heat tube is placed around the
light source 126 and the heat tube directs heat away from the
patient towards the proximal end 112 of the handpiece 102. At the
proximal end 112 of the optical therapy device 100, heat may be
released into the environment. In one embodiment, the heat tube
terminates in a structure optimized for heat transfer into the
surrounding environment, for example, cooling fins. Alternatively,
or in combination, in another embodiment, a fan is provided at the
proximal end 112 of the optical therapy device 100 and at the
proximal end of the heat tube. The fan provides active convection
to carry heat away from the optical therapy device 100.
[0144] In one embodiment, a controller 136 controls the power
output from the power supply 110 so that the light source 126 is
activated for a predetermined time period. The controller 136 may
include a switching mechanism that, in one embodiment, is
controlled external to the device. Such external control may be
implemented by any of a variety of mechanisms, such as, for
example, a radio frequency communicator. The controller 136 helps
avoid misuse or overuse of the optical therapy device 100. The
controller 136 may also allow optimization to be carried out by the
physician prescribing the device. In another embodiment, the
controller 136 provides for preset dose quantity and frequency. In
one embodiment, these parameters are set by the patient's
physician. In one embodiment, parameters are set by the controller,
a nurse, doctor, caregiver, patient, or other individual, or may be
set according to prescription set forth by clinician.
[0145] In one embodiment, the optical therapy device 100 includes
software (not shown) to control the dosage of optical energy to a
patient. In one embodiment, the energy, power, intensity, and/or
fluence of the optical output may be adjusted. Adjustments and
settings may be saved within or loaded onto the optical therapy
device 100 to correspond to the requirements of a particular
patient, or clinical result.
[0146] In one embodiment, the treatment dose includes timing
controls. Timing controls may include the amount of time the light
source 126 of the optical therapy device 100 may be activated for a
treatment. In another embodiment, timing controls include pulsing
parameters, such as pulse width, timing of optical pulses, or
relative sequence of pulses of light emitted from one or multiple
light sources 126. In one embodiment, the light source 126 provides
continuous (non-pulsed) optical output, and the timing controls
include the duration of treatment, the time between treatments, and
the number of treatments allowed in a specified time period, for
example, one day.
[0147] In another embodiment, such as described with respect to
FIG. 2 below, the controller 136 is not included within the
handpiece 102 of the optical therapy device 100. In such
embodiment, power delivery and timing controls are provided to the
handpiece 102 from a source (such as control unit 202) outside of
the handpiece 102. In such embodiment, the handpiece 102 may be
disposable, and the physician may control the doses to the
individual patient from a personal computer 204 or directly from
power supply components, such as described below in additional
detail.
[0148] The optical therapy device 100 may be used to treat or
diagnose any of a variety of diseases. In one embodiment, the
optical therapy device 100, is used to modulate immune or
inflammatory activity at an epithelial or mucosal surface.
Different immune and/or inflammatory reactions may be treated with
combinations of ultraviolet and/or white light. In one embodiment,
the optical therapy device 100 is used to treat allergic rhinitis,
chronic allergic sinusitis, hay fever, as well as disease states
such as dry eyes, allergic conjunctivitis or other immune-mediated
mucosal diseases. In addition, the optical therapy device 100 may
be used to treat any symptom associated with such conditions, such
as sneezing, rhinorrhea, palate itching, ocular itching,
congestion, and/or nasal itching. In other embodiments, optical
therapy device 100 is used to treat skin disorders such as
alopecia, acne, vitiligo, dermatoses, psoriasis, atopic dermatitis,
and scleroderma. In some embodiments, the optical therapy device
also diagnoses disease in combination with therapeutic delivery or
alone without therapy.
[0149] Allergic rhinitis is an immune mediated process resulting
from an allergen, such as ragweed, cat dander, mountain cedar, etc.
The allergen combines with IGE present in and on cells of the
mucosal surface of the nose or other mucosal surface, which leads
to the degranulation of mast cells. This releases histamine and
other mediators, which then lead to an immediate inflammatory
reaction as well as an organized immune response that may last for
days to weeks, or even months.
[0150] In other embodiments, the optical therapy device 100 is used
to directly treat microbial pathogens or non-pathogens, such as
fungi, parasites, bacteria, viruses that colonize, infect, or
otherwise inhabit epithelial and/or mucosal surfaces. For example,
patients with chronic sinusitis frequently have fungal colonization
or a frank infectious process leading to the disease process. One
clinical advantage of utilizing ultraviolet light to eradicate
infections is that it avoids problems associated with antibiotic
resistance. Antibiotic resistance is becoming an increasingly
difficult problem to contend with in the medical clinic. In
particular, patients with sinusitis generally undergo multiple
courses of antibiotic therapy, which is typically ineffective.
Antibiotic therapy is typically ineffective because the chronic
nature of the sinuses in chronic sinusitis leads to production of a
biofilm, which by its nature can prevent antibiotics from reaching
the sinuses. Adjunctive phototherapy is another weapon in the
armamentarium against microbes.
[0151] In some disease states, patients are allergic to allergens
shed by microbes, such as in allergic fungal sinusitis. Microbes,
and in particular fungi, are particularly sensitive to light with
wavelengths ranging from 250 nm to 290 nm. At these wavelengths,
the light directly affects the cellular macromolecules and can, for
example, crosslink and/or dimerize DNA. Although the 250-290 nm
wavelength light may be useful to injure or destroy pathogens,
light having higher wavelengths (e.g., 300-450 nm) can also lead to
cellular injury, albeit at higher optical powers. Ultraviolet light
in the range 150-250 nm can also be used to destroy pathogens.
[0152] When combined with other chemicals or pharmaceuticals (e.g.,
moieties), light of different wavelengths can be used to treat
pathogens. Such therapy, generally referred to as photodynamic
therapy, allows almost any wavelength of light to be used to cause
a biologic effect. This is because the light is absorbed by the
moiety, which causes a toxic effect. The moiety can be chosen based
upon its absorption characteristics, the light wavelength, or
molecular specificity.
[0153] In some cases, the moiety or chemical entity resides in or
around an epithelialized surface. For example, ultraviolet light
can induce oxygen to become ozone, which can spontaneously release
a toxic oxygen radical. The toxic oxygen radical can injure or
destroy the pathogens.
[0154] Other examples of photodynamic moieties include psoralen, a
DNA cross-linker, which has been used for many years in PUVA
treatment for psoriasis and other skin diseases because it
potentiates the actions of UVA. Another FDA approved and widely
used photodynamic therapy is 5-aminolevulinic acid which is a
photosensitizer with an absorption maximum at 630 nm and which
generates oxygen free radicals upon light exposure. More recently,
photodynamic moieties have become increasingly complex and can
include nanoparticles, such as those described by Loo, et al. in
Nanoshell-Enabled Photonics-Based Imaging and Therapy of Cancer,
3(1) Technol Cancer Res Treat 33-40 (February 2004), which is
incorporated by reference.
[0155] Nanoparticle-based therapy systems allow for wavelength
tuning so that the wavelength of maximal absorption can be
customized to the application. Nanoparticles also allow for surface
modifications so that the particle can target a specific tissue and
then when the light focuses on that particular region, the
specifically targeted nanoparticle will absorb the specific
wavelength of light; therefore, regional specificity as well as
wavelength specificity can be achieved with one particle. It is
possible that the moieties resonate in response to specific
frequencies (e.g., on-off frequency as opposed to electromagnetic
frequency) in addition to wavelengths so that certain particles are
activated when the optical therapy device deliver light of specific
wavelength and with a specific on-off frequency.
[0156] When it is desired to treat microbes at epithelial or
mucosal surfaces, such as the sinuses, an optical therapy device
100, including a mercury vapor lamp light source 126, may be
utilized. Such a light source 126 generally emits light primarily
at a 254 nm wavelength, which can destroy bacteria, fungi, viruses,
and even fungal spores (discussed above). In other embodiments, an
array (e.g., one or more) of light emitting diodes (LEDs) or laser
diode modules is used. The array emits light (typically in the
ultraviolet C and short wavelength ultraviolet B regimes) at one or
more wavelengths selected to destroy polynucleotides (e.g., DNA
and/or RNA), cell membranes, and/or proteins of the pathogens. In
other embodiments, LEDs are used in photodynamic therapy and
activate the moiety to exert its biologic effect.
[0157] An optical therapy system 200, in accordance with another
embodiment of the present invention, is illustrated in FIG. 2. The
optical therapy system 200 includes an optical therapy device 100,
a control unit 202, and at least one computer 204. Control unit 202
communicates with optical therapy device 100 via power coupling
114, such as power coupling 114 described above, with respect to
FIG. 1. Power coupling 114 may provide communication of power and
electronic control signals between control unit 202 and the optical
therapy device 100. The control unit 202 is also coupled to at
least one computer 204 via computer coupling 206. Computer coupling
206 may be any of a variety of structures, devices, or methods
known to those of skill in the art that enable communication
between computers or computing devices. For example, in one
embodiment, computer coupling 206 is a cable, such as a USB or
Ethernet cable. In another embodiment, the computer coupling 206 is
a wireless link. The at least one computer 204 may include a
personal computer, such as a PC, an Apple computer, or may include
any of a variety of computing devices, such as a personal digital
assistant (PDA), a cellular telephone, a BLACKBERRY.TM., or other
computing device.
[0158] Computer coupling 206 may include any wired or wireless
computing connection, including a Bluetooth.TM., infrared (e.g.,
IR), radiofrequency (e.g., RF), or IEEE 802.11(a)-, (b)-, or
(g)-standard connection. Control unit 202 and computer 204 may form
a network within which multiple computers 204 or computing devices,
or control units 202 may be included.
[0159] In one embodiment, control unit 202 is connected to a power
supply via a power cord 208. Control unit 202 also generally
includes a display 210, a keypad 212, controls 214, and a cradle
216. Display 210 may include a screen or other output device, such
as indicators, lights, LEDs, or a printer. In some embodiments, the
display 210 is of the touchscreen variety and includes touch
controls to control the parameters of the optical therapy device
100. Controls 214 include any of a variety of input devices,
including knobs, levers, switches, dials, buttons, etc. In some
embodiments, cradle 216 is adapted to receive the handpiece 102 of
the optical therapy device 100 when not in use. Such a cradle 216
may furthermore be configured to provide electrical power (e.g., a
rechargeable battery) to the handpiece of the optical therapy
device 100 and/or control signals. In such embodiment, power
coupling 114 may not be provided, or may be provided via the cradle
216 through electrical contacts. In some embodiments, the cradle
216 includes an optical detector, such as a photodiode, which can
provide an indication of the output or strength of the optical
light source 126 and can provide for calibration of the optical
therapy device 100 over time.
[0160] FIG. 3A illustrates one embodiment of the use of the optical
therapy device 100. In the illustrated embodiment, the user (e.g.,
medical practitioner, nurse, doctor, or patient) holds the
handpiece 102 of the optical therapy device 100 and inserts the
tube 106 into his or her nose 300 (or into the nose of the patient
when the medical practitioner is the user of the device). The
light-emitting distal end 116 of the reflecting tube 106 is
inserted inside of the nasal cavity 302 of the patient. Light is
emitted from the optical therapy device 100 along a light
propagation access 304 where it is absorbed by the mucosa and other
soft tissues within the nasal cavity 302.
[0161] FIG. 3B illustrates one embodiment of an optical therapy
device 100 adapted to be inserted into the paranasal sinus cavities
154,to treat conditions such as sinusitis. Optical therapy device
100 has a specific shape or contour to reach the sinus as will be
described below. The various wavelengths of the optical therapy
device 100 may be chosen depending upon whether fungal sinusitis or
allergic sinusitis is to be treated. When allergic sinusitis is to
be treated, wavelengths including visible light and ultraviolet
light may be utilized. In the case where it is desired to treat
fungi and/or other microbes, a lower wavelength, such as from
250-300 nm, may be used. In some cases, it is desirable to use all
of these wavelengths separately or in combination, sequentially or
concomitantly.
[0162] Although the optical therapy device 100 is illustrated and
described herein as used for treating a patient's nose 300, the
optical therapy device 100 may be adapted to treat any of a variety
of cavities, surfaces, portions, or organs of the human or animal
body. For example, in one embodiment, the optical therapy device
100 is adapted to treat the skin, or to be inserted into and treat
tissue within the mouth, ear, vagina, stomach, esophagus, small
intestine, bladder, renal pelvis, rectum and/or colon. For example,
the optical therapy device 100 may be used to reduce inflammation
within any mucosa of the body.
[0163] Furthermore, the optical therapy device 100 may be inserted
into a body cavity to treat the walls of an organ without entering
the lumens of the organ or the organ itself. Such is the case, for
example, when the optical therapy device 100 is placed inside the
chest cavity to treat the lungs, heart, or the esophagus. Such is
also the case when the optical therapy device 100 is placed inside
of the abdominal cavity to treat the intestines, stomach, liver, or
pancreas. The optical therapy device can be adapted for insertion
through a laparoscope, hysteroscope, thoracoscope, endoscope,
otoscope, bronchoscope, cystoscope, or cardioscope.
[0164] In one such embodiment, the optical therapy device 100 is
used to treat the clinical disease state of diastolic heart
failure. In diastolic heart failure, collagen deposition in between
or in place of (as is the case of ischemic cardiomyopathy) the
myocardial fibers lead to a decreased compliance of the myocardium
and a failure of the myocardium to relax properly during diastole.
Ultraviolet light therapy, specifically ultraviolet A (UVA) light
therapy, can activate the native collagenase system in human skin
and lead to an increased compliance in diseases such as
scleroderma, as discussed in greater detail above. A similar
collagenase system is present within the myocardium and if
activated, can decrease the compliance of the myocardium with a
similar mechanism as in the skin.
[0165] In one embodiment, the optical therapy device 100 is adapted
to treat inflammation and/or infection of the gastrointestinal
tract caused by any of a variety of conditions, such as, Crohn's
disease, ulcerative colitis (inflammatory bowel diseases), C.
difficile colitis, and/or esophagitis. In some embodiments, the
optical therapy device 100 can ameliorate the internal consequences
of T-cell-mediated diseases, such as autoimmune and collagen
vascular diseases, such as rheumatoid arthritis, systemic lupus
erythematosis, psoriatic arthritis, etc. In some embodiments, the
optical therapy device 100 is adapted to treat skin conditions,
such as psoriasis. In yet another embodiment, the optical therapy
device 100 is adapted to be inserted into the vagina to treat any
of a variety of conditions, including yeast infection, vaginitis,
vaginosis, Candida, parasites, bacteria, and even an unwanted
pregnancy. The optical therapy device 100 may be inserted within
the ear, and deliver light to the external or internal auditory
canals to reduce inflammation and/or infection therein. In yet
another embodiment, the optical therapy device 1 00 may be provided
to the bladder, kidney, ureter, and/or urethra to treat and/or
reduce inflammation. The optical therapy device 100 may also be
used to treat rheumatoid arthritis, or to reduce or eliminate
herpetic lesions (e.g., cold sores) by decreasing viral shedding
time and/or time to healing.
[0166] In yet another embodiment, the optical therapy device 100 is
adapted for veterinary use. For example, in one embodiment, the
optical therapy device 100 is adapted to be inserted inside the
nose of an equine, such as a racehorse, to treat rhinitis, reduce
inflammation, or treat any of the diseases of conditions described
herein. Other animals may benefit from treatment with the optical
therapy device 100, including domestic animals, such as dogs, cats,
and rabbits, as well as exotic animals, such as cheetah, gorilla
and panda.
[0167] An optical therapy device 100, in accordance with another
embodiment of the present invention, is illustrated in FIG. 4. The
optical therapy device 100 of FIG. 4 includes a handpiece 102 and
tube 106 similar to the optical therapy devices discussed above. In
addition, the optical therapy device 100 of FIG. 4 includes
multiple light sources 126. For example, as illustrated, optical
therapy device 100 includes three light sources 126. Any number of
light sources 126 may be utilized, including one, two, three, or
more than three light sources 126. Light source 126 may be a
bulb-type light source, such as a mercury vapor lamp or filament
based light source, as discussed above, or an LED light source, or
a combination thereof. Any of the control systems and power
delivery systems discussed above may be incorporated into the
optical therapy device 100 of FIG. 4.
[0168] Although the multiple light sources 126 of FIG. 4 are shown
in close proximity, individual light sources 126 can be placed
anywhere along the tube 106 or handpiece 102. In one embodiment,
the light source(s) 126 is (are) located close to the distal tip
118. For example, in one embodiment, a UVB emitting source is
placed close to the distal tip 118 and a white light source and/or
UVA light source are/is placed proximally, toward the handpiece
102. Such a configuration can assure that UVB wavelengths reach the
nasal mucosa because in many cases UVB light is difficult to
transport faithfully. Even though the UVA and white light sources
126 may have more losses than the UVB light source 126, this is
acceptable since, in at least one embodiment, the UVA and white
light sources 126 generate a higher amount of optical energy or
power and typically undergo less loss along an optical guidance
system than UVB light.
[0169] An optical therapy device 100 in accordance with yet another
embodiment of the present invention, is illustrated in FIG. 5A.
Optical therapy device 100 includes a tube 106 and a handpiece 102,
such as those described above with reference to FIGS. 1-4. However,
in the present embodiment, optical therapy device 100 includes a
passive cooling mechanism integrated therein. In one embodiment,
the passive cooling mechanism includes a cooling sleeve in thermal
communication with a heat diffuser 502 located at the proximal end
112 of the handpiece 102. A thermal interface 504 covers at least a
portion of the proximal end 112 of the handpiece 102, and provides
for dissipation of heat from the heat diffuser 502. In one
embodiment, the cooling sleeve at least partially surrounds light
source 126 of the handpiece 102.
[0170] The cooling sleeve may be made from any of a variety of
thermally conductive materials, including aluminum, copper, steel,
stainless steel, etc. In addition, the cooling sleeve may be filled
with a thermally conductive material or a cooling material such as
water, alcohol, freons, dowtherm A, etc. For higher temperature
lamps, the cooling fluid could include sodium, silver, and others
materials as are generally well-known in the art. In one
embodiment, heat diffuser 502 includes cooling fins to increase its
surface area. Increased surface area of the heat diffuser 502
provides efficient cooling for the light source 126 of the optical
therapy device 100. The thermal interface 504 and/or heat sink 502
may be made from any of a variety of thermally conductive
materials, including metals, such as aluminum, copper, steel,
stainless steel, etc. The rounded surface of the thermal interface
504 protects the user and his or her hand from sharp or jagged
edges of the heat sink 502. The thermal interface 504 can further
be perforated to allow for convective flow from the heat sink
502.
[0171] In one embodiment, cooling sleeve is or includes a series of
cooling pipes, or heat pipes 500, as is well-known in the art, such
as those illustrated in FIGS. 5A-5B. Heat pipes 500 extend axially
along the longitudinal axis of the handpiece 102 and generally run
parallel to the light source 126.
[0172] A cross-sectional view of optical therapy device 100, taken
along line 5B-5B, is illustrated in FIG. 5B. In the illustrated
embodiment, a circumferential arrangement of heat pipes 500 is
shown. As is well-known in the art, heat pipes 500 include a liquid
(the coolant) that generally has a boiling point in the range of
temperature of the portion to be cooled. Common fluids include
water, freons, and dowtherm A, which has a boiling point
temperature range of about 500-1000.degree. C. A second portion of
the heat pipe 500 is a wicking portion, which transmits the coolant
in its liquid state. The coolant picks up heat at the hot region
(e.g., proximate to the light source 126), is vaporized and travels
down the center of the pipe, where the fluid then condenses at the
cooler portion of the heat pipe 500, and then wicks back through
the wicking portion of the heat pipe 500. The configuration of heat
pipes 500 in FIG. 5B is only one example of any numerous shapes,
sizes, and configurations of heat pipes 500, which may include
flat, horseshoe shaped, annular, as well as any other shape. The
heat pipes 500 can be placed anywhere along the tube 106 and even
at its distal portion. The heat pipes 500 can be used in
combination with any of the configurations, devices, and light
sources above.
[0173] FIG. 6A and FIG. 6B illustrate an optical therapy device 100
in accordance with yet another embodiment of the present invention.
In one embodiment, a fan 610 is provided near the distal end 104 of
the handpiece 102 to actively transfer heat away from the optical
therapy device 100. Handpiece 102 also includes at least one light
source 126 as described in greater detail above. The fan 610
provides for active cooling by pulling air 603 into the handpiece
through distal heat vents 600, through the handpiece 102 (e.g., in
the direction of the arrows) via channel 602, and out the proximal
end 112 of the handpiece 102 via heat vents 604 located in the
thermal interface 504. In some embodiments, fan 610 is used in
conjunction with fins, heat pipes, cooling pipes, cooling sleeves,
and/or cooling tubes as described above. In another embodiment, fan
610 provides cooling by pulling or pushing air through the
handpiece 102.
[0174] In another embodiment, such as illustrated in FIG. 6B, fan
610 is located at the proximal end 112 of the handpiece 102. Air is
pulled through a channel 602 in the handpiece via distal heat vents
600. Air flowing through the handpiece 102 via channel 602 removes
heat from light source 126. In this manner, the light source 126 is
cooled.
[0175] An optical therapy device 100 in accordance with another
embodiment of the present invention is illustrated in FIG. 7A.
Optical therapy device 100 includes handpiece 102 and tube 106, as
described above with respect to FIGS. 1-6B. However, in the present
embodiment, the light source 126 of the optical therapy device 100
is located at the distal end 116 of tube 106 near its distal tip
118. In the illustrated embodiment, tube 106 may not be configured
to guide or reflect light since the light source 126 is located at
or near its distal end 116. The tube 106 may be configured to guide
light in cases when light exiting the tip of the device 118
includes light originating in the handpiece 102 and at the distal
tip 118 of the tube 106.
[0176] As discussed above, light source 126 can be any of a number
of different light sources. In one embodiment, light source 126 is
an LED or multiple LEDs. In another embodiment, light source 126
includes one or more LEDs for generating UVB light and one or more
LEDs for generating white light and/or UVA light. Additional light
sources 126 can be combined (e.g., at the distal end 116), or one
or more light sources 126 can be located closer to the proximal end
112. Of course, in this embodiment, an optical guidance system may
be used to transmit or guide the light generated by the light
source 126 located in the handpiece 102.
[0177] Since, in one embodiment, the majority of heat generated by
the light source 126 is generated at the light source's distal end,
heat pipes 500 are used to remove the heat therefrom. In one
embodiment, when the light source 126 includes a double-bore
mercury vapor lamp, optical emitter 128 is a double-bore quartz
capillary tube. Mercury vapor lamps typically generate heat at
their cathode and anode, which are generally located at the ends of
the inner capillary tube. Therefore, in some embodiments, heat is
generated primarily at the ends of the inner capillary tube. In
another embodiment, when light source 126 consists of LEDs, optical
emitter 128 is the chip array or package used to create light, such
as solid state light. Heat generated at the circuitry may be
carried away from the distal end 116 by heat pipes 500. In the case
when light source 126 is an LED or a combination of LEDs, the heat
generation from the conversion from electricity to light is
minimal, or less significant; however, significant heat can be
generated in the circuitry--especially when several LEDs are used
in combination. In such and other cases, heat pipes 500 including
heat conduction rods produced from materials that have good thermal
conductivity, such as aluminum, copper, steel, stainless steel,
etc., may be used.
[0178] Heat pipes 500 generally run parallel to the light source
126 along the axial length of the optical therapy device 100. Heat
is transmitted, or is conducted, through the heat pipes 500 to the
heat sink, as discussed in greater detail above. In other
embodiments, heat pipes 500 are circumferentially wrapped around
the light source 126 or tube 106.
[0179] Heat is carried from the light source 126 through the heat
pipes 500 to the heat sink 502 located at the proximal end 112 of
the handpiece 102. In one embodiment, heat is dissipated from the
handpiece 102 through a heat sink 502 (which may include cooling
fins), after which the heat exits handpiece 102 via a thermal
interface 504.
[0180] FIG. 7B shows a cross-section of the optical therapy device
100 of FIG. 7A along line 7B-7B.
[0181] FIG. 8A illustrates an optical therapy device 100 in
accordance with yet another embodiment of the present invention.
Optical therapy device 100 includes a handpiece 102 and tube 106
(which may or may not be a reflecting tube depending on the
combination of light sources used) as described in greater detail
above. In the present embodiment (illustrated in FIGS. 8A and 8B),
light source 126 is located near the distal end 116 of the tube 106
similar to that described above with respect to FIG. 7A. However,
in the present embodiment, light source 126 includes a solid state
array of light sources, or a multitude of light sources arranged in
a two- or three-dimensional array. In the case where all the
desired wavelengths are emitted from the diode array, tube 106 does
not have to be a reflecting tube. In such cases, the tube 106 can
serve as a conducting tube for heat transfer (depending on the
number and efficiency of the light emitting diodes, specialized
heat transfer may or may not be employed). In addition, the tube
106 may be made from a soft, flexible material comfortable to the
patient. In some embodiments, only certain wavelengths are provided
by LED array and other wavelengths are transmitted through an
optical tube 106, as described above.
[0182] A cross-sectional view of optical therapy device 100 taken
along line 8B-8B is illustrated in FIG. 8B. A diode array light
source 126 is illustrated in the cross-section view of FIG. 8B. In
one embodiment, all desired wavelengths are provided by the array
126, and a region 127 is adapted to transfer heat by any or all of
the mechanisms discussed above. The region 127 can also be used to
transmit additional optical spectra through optical fibers, tubes,
or any of the devices described above.
[0183] FIGS. 9A-9H represent optical therapy devices 100 having
different tubes 106 in accordance with alternative embodiments of
the present invention and generally configured to treat the sinuses
of a patient. The handpiece 102 is shown in a cutaway view, as it
may be substantially the same for these embodiments. Each tube 106
is configured to optimize a particular parameter based upon
specific clinical needs and/or reach a particular body region such
as the maxillary sinus, the ethmoid sinus, the frontal sinus, etc.
As such, tubes 106 having varying lengths, shapes, curvatures,
diameters, radiuses, bends, and tapers may be utilized or selected
by a clinician as required. The tube 106 may also have light
sources 126 placed anywhere in, on, or along the tubes 106. In some
embodiments, the tube 106 is not optically reflecting because the
light is generated at its distal end. In such embodiment, the tube
106 may serve as a conduit for electrical or heat transfer.
[0184] In the optical therapy device 100 illustrated in FIG. 9A,
handpiece 102 is connected to reflecting tube 106 that has a bend
at its distal end 116. The distal end 116 of the tube 106 is bent
at a bend angle 900 to create a distal segment 902. The distal
segment 902 has a distal length 904 that may be selected to
configure to the anatomy of a particular patient. In some
embodiments, optical therapy device shown in FIG. 9A is utilized to
treat the sinuses of a patient.
[0185] In some embodiments, tip 902 can be flexible and may include
a hinge (not shown) and/or a flexible material so that angle 900
can be adjusted by the practitioner. A light source 126 or
combinations of light sources 126 can be placed anywhere along tube
106 as described above. The light source 126 can also reside in
handpiece 102, as described above. Tube 106 can also contain an
optical fiber bundle or it can be hollow and configured to reflect
light, as discussed above. Furthermore, depending on the light
source 126 selected, the tube 106 can be configured to transfer
heat from the light source 126, as described above.
[0186] Similarly, as illustrated in FIG. 9B, optical therapy system
100 includes a handpiece 102 that is connected to a reflecting or
non-reflecting tube 106 having a distal segment 902 of a different
bend angle 900 at its distal end 116. The distal length 904 of the
distal segment 902 may be the same or different than that of FIG.
9A. In addition, the bend angle 900 is shown at a greater angle
than that shown in FIG. 9B is greater than that shown in FIG. 9A.
Similarly, such designs are used to reach the sinuses or other
internal cavities or surfaces of a patient.
[0187] The distal length 904 of the distal segment 902 may be
varied as clinically required, as illustrated in FIG. 9C. The
distal length 904 may vary between 1 cm and 4 cm. Proximal length
905 varies between about 6 and 12 inches. Bend angle 900 varies
from about 45-60 degrees in some embodiments, and from about 60-80
degrees in other embodiments.
[0188] An optical therapy device 100 in accordance with yet another
embodiment of the present invention is illustrated in FIG. 9D. The
optical therapy device 100 of FIG. 9D includes a handpiece 102
coupled to a reflecting tube 106 that includes an expandable
balloon 906 at the reflecting tube's distal end 116. The reflecting
tube 106 may be inserted into a patient's nose and/or sinus and the
expandable balloon 906 may thereafter be inflated with a liquid,
gas, polymer, a hydrogel, or a combination thereof, including a
combination of fluids. By inflating the expandable balloon 906, the
tissue (e.g., mucosa) on the inside surface of the patient's nose
or sinus is flattened out to allow a more even distribution of
light energy thereto. In addition, inflating the expandable balloon
906 allows the optical therapy device 100 to be positioned within
the patient's body in such a way as to allow more exposure of
mucosal surface area. The temperature of the fluid inserted into
the balloon described above can be varied from low temperature
(e.g., lower than body temperature) to high temperature (e.g.,
above body temperature) to treat the mucosa of the sinuses and to
work independently or synergistically with the optical therapy
device 100.
[0189] In one embodiment, the compression balloon 906 is made from
an optically transparent material; for example, a material which is
transparent to ultraviolet light. Examples of transparent materials
include certain formulations of PVDF as can be found in Japanese
Patent No 01241557, which is incorporated by reference herein;
certain fluoropolymers such as fluorinated ethylene propylene (FEP)
produced by Zeus Inc; certain derivatives of Teflon (e.g.,
Teflon-AF produced by Dupont); certain formulation of silicone;
and/or certain elastomeric formulations of silicone dioxide. The
balloon may be compliant or non-compliant and may have single,
double or multiple lumens.
[0190] The compression balloon 906 may be inflated by passing a
fluid, liquid, gas, or a combination through an inflation lumen 908
from the handpiece 102 to the compression balloon 906. The
compression balloon 906 may be deflated in a similar matter.
[0191] The reflecting tube 106 of the optical therapy device 100
may include more than one distal segment 902 such as is illustrated
in FIG. 9E. In the embodiment of FIG. 9E, optical therapy device
100 includes a tube 106 having two distal segments 902. In one
embodiment, the distal segments 902 have equal distal lengths 904
although in other embodiments, the distal lengths of the distal
segments 902 are different.
[0192] In another embodiment, the distal segments 902 are flexible
so that the relative spacing 903 between the distal segments 902
may be adjusted to accommodate the anatomy of particular patients.
Incorporating more than one distal segment 902 can be highly
beneficial in the clinical setting since the total amount of time
the patient spends receiving the optical therapy may be reduced.
This results in improved patient compliance because of the
decreased treatment times.
[0193] In one embodiment, the distal segments 902 are parallel to
one another although in other embodiments, they are not. In one
embodiment, each distal segment is oriented at an angle with
respect to the axis of the reflecting tube 106. For example, in one
embodiment, distal segment 902 projects at an angle between about 1
and 15 degrees with respect to the axis of the reflecting tube
106.
[0194] In the distal segments 902, flexibility may be achieved by
forming the distal segment 902 from a flexible material. For
example, the distal segment 902 may be manufactured from a polymer
coated in rubber or a thin metal sleeve coated in rubber or other
flexible coating. In other embodiments, the optical therapy device
100 (such as the optical therapy device illustrated in FIG. 9E)
includes pivots (not shown) on the end of each of the distal
segments 902, which may be parallel. Pivots will allow for the
parallel end of the optical therapy device to move or be moved
independently of the linear portions of the parallel reflecting
tubes 902.
[0195] An optical therapy device 100, in accordance with another
embodiment of the present invention, is illustrated in FIG. 9F. The
optical therapy device 100 includes a handpiece 102 and a tube 106.
At the distal end 116 of the tube 106 is a rotational member 910
mounted thereto. Rotational member includes an aperture 912 through
which light energy emitted from the light source 126 may be
transmitted. In one embodiment, the rotational member 910 is able
to rotate about an axis parallel to the central axis of the
reflecting tube 106.
[0196] In one embodiment, the rotational member 910 is shaped to
focus the light from the light source 126 to the aperture 912 of
the rotational member 910. The rotational member 910 is, in one
embodiment, substantially non-transmissive and substantially
reflects all of the light emitted by the light source 126 to the
aperture 912. By rotating within the nose, the rotational member
910 is able to provide the light from the light source 126 through
the aperture 912 to the soft tissue of the inside of the nose or
other body cavity in a circumferential manner.
[0197] FIG. 9G illustrates another optical therapy device in
accordance with yet another embodiment of the present invention. In
the optical therapy device 100 of FIG. 9G, tube 106 includes light
guides 114 mounted at the tube's distal end 116. Adjustable light
guides 914 may be oriented at an adjustment angle 916 with respect
to the tube 106.
[0198] In one embodiment, adjustment angle 916 may be adjusted
between an angle of about 0 and about 60 degrees with respect to
the reflecting tube 106. In another embodiment, the adjustment
angle is between about 10 and 30 degrees.
[0199] The inside surface of the adjustable light guides 914 are
generally reflective or covered with a reflective material so that
light emitted from the light source 126 reflects off the adjustable
light guides onto the tissue on the insider surface of the nose.
The outside surface of the adjustable light guide is generally
covered with a nonabrasive material or coating that is comfortable
to a user when inserted inside or his or her nose.
[0200] An optical therapy device 100, in accordance with yet
another embodiment of the present invention, is illustrated in FIG.
9H. The optical therapy device 100 of FIG. 9H includes a handpiece
102 coupled to a tube 106. The tube 106 includes multiple apertures
916 at its distal end 116. Apertures 116 may be provided around the
entire circumference of the reflecting tube 116 or may be provided
on only one side or along only a selected portion of the reflecting
tube 106.
[0201] The apertures 916 may be between 0.1 and 1 mm in diameter,
or may be between 0.5 and 2 mm in diameter. The apertures 916 may
be spaced between 0.5 to 1.0 mm, or between 1 to 3 mm from one
another. In one embodiment, the distal end 116 of the tube 106
includes at least four apertures. In another embodiment, tube 106
includes between two and ten apertures. In another embodiment, tube
106 includes greater than ten apertures. Apertures 916 allow light
emitted from light source 126 to escape from the insider of the
tube 106 and enter the patient's nose. In this embodiment, light is
emitted through the apertures 916 of the reflecting tube 106 in a
longitudinal fashion (e.g., along the length of the tube) rather
than at a distal end alone.
[0202] FIGS. 9I-9J illustrate additional embodiments of the present
invention. Handpiece 102 is connected to a flexible component 122
which has a lumen 125 within flexible component 122. As described
above and below, flexible component 122 can transmit light, can
comprise the pathway to transmit electrical power, conduct heat, or
can perform all three functions. Lumen 125 is sized to at least
allow a second flexible device such as a guidewire 120 (well-known
in the medical device arts) to pass through. The guidewire can
allow for access to small orifices such as those which lead to the
sinuses. After the guidewire 120 gains access to or purchase in the
desired small orifice, the catheter 122 is fed over the guidewire
120. The guidewire 120 can have an expandable component 124, such
as a balloon or anchor, on its end, such that the expandable
component 124 can hold the guidewire 120 in the nose. The optical
therapy can then be delivered through the guidewire with therapy
that is generated by a light source located along the body or
handpiece of the optical therapy device and delivered to the
expandable component, or light can be generated in the expandable
component 124. In the embodiment illustrated in FIG. 9J, a light
source 127 is located at the distal end of the guidewire 120.
[0203] FIG. 10A illustrates a light emitting diode (LED) device 500
in accordance with one embodiment of the present invention. FIG.
10C illustrates a recording by a spectroradiometer of the optical
output from an LED device 500 that emits light centered at a 308 nm
wavelength peak. In the illustrated embodiment, the total output
(e.g., optical power or area under the spectral output curve) at
the 308 nm wavelength peak is in the range of from about 0.1
.mu.W/cm2 to about 500 .mu.W/cm2, from about 500 .mu.W/cm2 to about
1 mW/cm2, or from about 1 mW/cm2 to about 5 mW/cm2 .
[0204] FIG. 10A shows the size of the LED device 500 relative to an
average size finger. The temperature of the LED 500 is often
negligible, as it can be held in one's hand as shown without a
perceptible temperature change. Embodiments of an LED package 502
are provided in FIGS. 10A and 10B. The package 502 includes its
ordinary meaning and also generally refers to the structures
supporting the LED chip 504, including the electrical leads 510,
511, the heat conducting element 506, and the covering optical
element 508. Covering optical element 508 can accomplish a number
of functions, including conditioning the light. Conditioning can
include diffusing the light from the LED chip, focusing the light
from the LED chip, directing the light, combining the light with a
phosphor, or mixing and combining the light from multiple chips.
Although one spectral peak is shown for the LED 500 of FIG. 10C, in
another embodiment, the LED 500 has more than one spectral peak.
For example, multiple chips (e.g., dies) may be included in the
same LED package 502. In another embodiment, the multiwavelength
spectrum emanates from one chip. The spectrum of one embodiment of
a multi-wavelength, multi-chip LED 500 (mLED) is illustrated in
FIG. 10E. The arrows of FIG. 10E point to the mLED's spectral
peaks, which, in the illustrated embodiment, occur at 308 nm, 310
nm, 320 nm, and 330 nm.
[0205] The MLED device 500 appears (on the outside) the same as LED
device 500 of FIG. 10A; however, on the inside of the package, 502
there may be differences in that the individual diode chips (e.g.,
dies) are assembled in a cluster, or chipset. Each diode chip
(e.g., die) can further be driven at an independent current (e.g.,
20 mA) and its duty cycle (e.g., the ratio of the on time divided
by the sum of the time and the off time) can be adjusted
independently. The drive current is generally directly proportional
to the optical output power and the optical efficiency is
substantially unchanged at low temperatures. The duty cycle
variable determines the amount of optical power available from each
led die. For example, LED dies typically become less efficient at
higher temperature (for example, due to an increase in resistance)
and will generate more heat than light per electron than they would
at lower temperature. If the "on" time is a small fraction of the
"off" time, then the chip has time to cool down; therefore the
short burst of current during the "on" period can result in a short
duration of very high power. Thus, despite the fact that the
relative power at each wavelength is shown to be similar in FIG.
10E, the relative power of each die can be varied using a
combination of current and duty cycle.
[0206] The total optical power provided by the LED devices 500 of
FIGS. 10A-E may be in the range of between approximately 100 .mu.W
and approximately 1 mW, between about 1 mW to about 5 mW, or
between about 5 mW to about 15 mW. Depending on the light
conditioning structure 508, the intensity of the output can be
concentrated greatly into a smaller spot size. Focused intensities
can range from about 1 mW/cm2 to about 1 W/cm2 depending on how
small the spot size is at the focal distance. The focal distance
can range from 0.5 mm to 10 mm depending on the focal length of the
light conditioner.
[0207] In one experiment, the device depicted in FIG. 10A was
attached to the skin of a human subject. After 14 minutes, the
device was removed. Within the following 12 hours, a "sunburn" was
detected over an area of 1 cm2 thereby demonstrating a biological
effect of the ultraviolet semiconducting structures (UV LEDs).
[0208] FIG. 10B illustrates a partial exploded view of the LED (or
MLED) package 502 of FIG. 10A. The light emitting portion of the
package includes LED chips (e.g., dies) 504 on a platform 506. The
platform is also referred to as the header, submount, or
combination of header and submount, and can serve as a heat
dissipating module. Typical LED chips include several semiconductor
layers having specific bandgap differences between them. When
voltage is applied across the semiconductor, light of a particular
wavelength is emitted as the current flows through the different
layers of the die.
[0209] An LED chip 504 can be a cluster of multiple chips
(otherwise referred to as a chipset) located on a platform 506, as
shown in FIG. 10B. The platform 506 can include a heat transferring
element. For example, the heat transfer element can be a ceramic
heat sink and/or diffuser. Alternatively, the heat transfer module
can be an active device, such as a thermo-electric cooling device.
Such heat transfer modules are well known to those skilled in the
art of semiconductor and LED packaging. Additional elements on the
platform 506 include reflectors, which are also well known to those
skilled in the art. A light conditioner in the form of a lens 508
can receive and direct light from the LED chip or chips 504 as
desired. In one embodiment, the lens 508 focuses the light from the
LED cluster 504. The lens 508 can be made from materials which are
generally transparent to the wavelengths of interest (e.g.,
silicone or quartz). In another embodiment, the conditioner 508
scatters or diffuses light from the LED cluster 504. In another
embodiment, the conditioner 508 contains a coating or contains
particles within the material of the conditioner 508 which act as
phosphors to alter the wavelength of output. In another embodiment,
the conditioner 508 configures the pattern of light to generate a
relatively uniform illumination pattern in an internal body cavity,
such as the nasal cavity. For example, in one embodiment, the lens
508 projects light to 70% of the exposed area of a body cavity
(e.g., the nasal cavity) such that the illumination is
substantially uniform (for example, does not vary more than 10%-20%
across the surface of the body cavity).
[0210] The LED chip or chips 504 can include about 1-5 LED chips,
about 5-10 LED chips, about 11-20 chips, or greater than about 20
chips. The electrical power to each chip can be controlled
independently by one or more of the leads 511 of FIG. 10B. The
leads 511 can be extended and/or combined into a larger connector,
leads or computer bus, 510. Furthermore, in addition to power, the
duty cycle of one or more of the chips in the chipset 504 can be
controlled independently and may be turned on or off at any given
time. For example, the duty cycle of an individual or multitude of
chips 504 (e.g., dies) can be controlled at a frequency of from
about 1 Hz to about 1000 Hz, from about 1000 Hz to about 10,000 Hz,
from about 10 kHz to about 1000 kHz, from about 1 MHz to about 100
MHz, from about 100 MHz to about 1 GHz, and/or from about 1 GHz to
about 1000 GHz. It may be desired to have a very high frequency for
its own sake and not to limit the heat generation from the chip or
chips.
[0211] Thus, it is possible to integrate such packaged LED chips
(e.g., mLEDs) into a medical device to perform phototherapy to
treat diseases (as discussed above and below) with a defined or
pre-selected set of wavelengths and power outputs from an LED
package 502. The single and multichip packages 502 shown in FIG.
10B allows the light source of a medical device to be reduced in
size, and to be placed inside of catheters and endoscopes to
deliver phototherapy to internal organs, cavities, surfaces, and
lumens. The LEDs on such internal medical devices can be any of the
wavelengths from about 240 nm to well into the infrared portion of
the electromagnetic spectrum, such as for example, about 1.5 micron
wavelength electromagnetic energy. In addition, solid state
technology, specifically LEDs, allow for abrupt changes in spectral
output and illumination pattern. Standard light sources in use
today offer very limited control of spectral output, illumination
pattern, and on-off frequency. Furthermore, because the LED chips
can be placed anywhere on platform 506, the illumination pattern
(e.g., the optical power applied to specific tissue regions) can be
well controlled.
[0212] FIG. 10D illustrates the output from one embodiment of a set
of three white-light emitting LEDs (wLED). The relatively broadband
white light from these wLEDs is generated with a phosphor placed
between the light emitting chips and the protective casing 508
(e.g., epoxy) overlying the chips. The total output of the wLEDs in
this spectrum can be in the range of about 20 mW/cm2 to about 30
mW/cm2 , about 10 mW/cm2 to about 40 mW/cm2 , or about 5 mW/cm2 to
about 50 mW/cm2.
[0213] he package size of the wLEDs may be in the range of about 3
mm to about 4 mm, about 2.5 to about 5 mm, or about 2 to about 6
mm. The size of a wLED package is often smaller than that of a uLED
package. In addition, at least three fully packaged wLEDs can fit
into an area of about 1-2 cm in diameter. White light may therefore
be less expensive in terms of size and cost. In addition, white
light is often more easily transmitted through optical guidance
systems.
[0214] In other embodiments, LED chips are packaged as surface
mounts (SMTs) (such as those available from Nichia Corporation,
Southfield, Mich.), which may be produced in sizes as small as
about 1-3 mm, about 2-5 mm, about 0.5-3.5 mm, or smaller than about
3 mm in diameter and having white light power outputs from about 1
mW to about 100 mW. Surface mounts can be placed directly in the
LED package 502 (package within a larger package) shown in FIG. 10B
or the surface mounts can be placed along side of another LED
package 502.
[0215] In one embodiment, an ultraviolet LED, or uLED, is used
without an optical guidance system. The uLED may be placed at the
end of a probe that is inserted into a body cavity or is placed on
or close to an external surface of a patient. The external surface
of a patient includes the skin, conjunctiva, cornea, finger nails,
toe nail, etc. An internal body cavity includes the nasal cavity,
sinuses, tracheobronchial tree and any of the cavities mentioned
above; also included, are cavities, such as the chest, and organs,
such as the heart or lungs. The term probe is intended to have its
ordinary meaning, and in addition can mean any device, including
any of the devices 100 described herein. The probe may emit one
wavelength of ultraviolet light (e.g., one narrow band, such as may
be emitted by an uLED) or it can emit several wavelengths (e.g.,
peaks) of ultraviolet light (e.g., such as emitted by the MLED
described above). The probe can also combine several wavelength
peaks from the white light spectrum or it can combine a
phosphor-based white light LED system as described above to produce
almost any pattern of spectrum. The probe can also be used to cure
adhesive compositions inside the body.
[0216] In this embodiment, the probe (and light) are brought very
close to the treatment area, which has many beneficial effects in
treating disease. The probe being close to the treatment area also
creates a very beneficial economic effect in the sense that light
therapy is generated at the point of use rather than being
generated away from the point of use and then transported to the
point of use. Often times, the light-transport mechanism is highly
inefficient and costly. Light generation at the point of use also
facilitates providing a device that is disposable after one or
several uses.
[0217] FIGS. 11A-C illustrate additional embodiments of an optical
therapy device 100, which may incorporate any one of or a
combination of uLeds, wLEDs, and/or mLEDs as its light source 126.
The probe can also incorporate LEDs with individual wavelengths in
the white or infrared region of the electromagnetic spectrum. The
light source 126 can be located at the distal end of a probe 106
adapted to be inserted into a patient's body. The probe 107 may be
similar to or the same as the tube 106 described with respect to
the various embodiments discussed above. The device 100 has a
simplified structure when LEDs are used as the light source
126.
[0218] Because LEDs are efficient light generators and because they
emit a relatively narrow band of light, they generate very little
heat and can therefore be positioned at the distal end of the probe
107 and can be placed directly into a patient's or user's body
cavity. Because of the size of the mLEDs and uLEDs and their
minimal heat creation, they can be placed directly into the body
cavity of interest without an optical guidance system and with
minimal heat transfer requirement from the device. Thus, an optical
guidance system may not be required for the ultraviolet light
portion of the action spectrum of the optical therapy device
100.
[0219] Such components and designs considerably simplify the device
100 in terms of the logistics of the therapy and ultimately the
cost of the device 100, particularly to the physician. The optical
portion (e.g., the LED chipset) can even be placed at the end of a
catheter, endoscope, or laparoscope and inserted into the body
cavity of interest. In this case, the probe portion between the
handle 102 and the light source 126 can be a long flexible
catheter, endoscope, or laparoscope, etc. The probe portion in this
embodiment is merely a structural element to allow control of the
light source 126 at the distal end of the device and deliver power
to the distal end of the device. The LED chipset at the end of the
device 100 provides the efficient light generation relative to heat
output and can minimize unwanted wavelengths in the spectrum. In
some embodiments, the LEDs chipset at the end of the catheters,
endoscopes, and laparoscopes deliver only white for the purpose of
visualization. In other embodiments, the LEDs deliver therapeutic
optical energy to a body region as discussed in many of the
embodiments above.
[0220] The spectral output of the device 100 of FIGS. 11A-D is
derived from combinations of the LEDs and LED packages shown in
FIGS. 10A-E, which can be centered in a single narrow band (e.g.,
when using an uLED), a summation of distinct bands (e.g., when
using a MLED), and/or combined with white light (e.g., either
phosphor based or through a combination of LEDs to produce to sum
to white light). Additional LED light sources 126 can also be fit
into the probe 107. Depending on the ultimate size of the probe 107
and the body cavity to which it is desired to apply therapy,
additional LEDs (e.g., white light LEDs with the spectral output
shown in FIG. 10D) can be added to achieve combinations of
ultraviolet light such as a combination of UVA, UVB, and white
light as described above and in U.S. patent application Ser. Nos.
10/410,690 and 10/440,690, filed Apr. 9, 2003 and May 19, 2003, and
published as U.S. Publication Nos. 2004/0204747 and 2004/0030368,
respectively, which are incorporated by reference herein.
[0221] FIG. 11B illustrates one embodiment of a device 100 that
incorporates white light generating LEDs 400 (as further
illustrated in FIG. 11C taken along line C-C of FIG. 11B) and an
ultraviolet emitting center portion 402 (as further illustrated in
FIG. 11D taken along line D-D of FIG. 11B). The illustrated
embodiment of FIG. 11B is similar to the uLED or the mLEDs depicted
in FIGS. 10A-D. The white light is transmitted from their
respective LEDs 400 (which may be surface mounted, chips, or
otherwise) through an optical guidance system (as illustrated in
FIG. 11D) and are directed into an annulus 404 around a uLED and/or
an mLED 402. The uLEDs and/or mLEDs may not have an optical
guidance system to transmit their light, for example, if they are
placed at or near the distal end, including at position D-D in FIG.
11B.
[0222] It is also possible to mount the surface mounted wLEDs
directly on the same chip platform as the mLEDs (e.g., at the level
D-D in FIG. 11B). Although in many cases, phosphor based wLEDs are
preferable, in other embodiments, the chip LEDs from the white
light spectrum (e.g. blue, green, red, amber, yellow dies, etc.)
are mounted directly on the chipset with the mLEDs and/or uLEDs
(see above) rather than using a phosphor based white light surface
mount and setting the entire surface mountable wLEDs behind the
ultraviolet LEDs. Independent of the final configuration, the
arrangement of light sources in FIGS. 11A-D generates an equivalent
or greater amount of optical power than the larger, less efficient
light sources (e.g., xenon, mercury vapor, halogen, etc.) discussed
above and at a fraction of the heat output, power, and cost. A
portion of the increase in efficiency may be due to the elimination
of the coupling steps required for more traditional light sources
(e.g., the requirement to collect the light and direct into an
optical fiber). LEDs and other semiconductor technology allow for
efficient and precise delivery of light to body surfaces and
cavities.
[0223] Such a device is also more portable and practical for a
medical practitioner or patient because the ultraviolet generating
light source is directly inside the body cavity or is positioned
directly on, in or adjacent the body surface. This arrangement of
LEDs also can obviate the need for a complex heat transfer system
within the optical therapy device or in a table top box as in U.S.
patent application Ser. Nos. 10/410,690 and 10/440,690, filed Apr.
9, 2003 and May 19, 2003, and published as U.S. Publication Nos.
2004/0204747 and 2004/0030368. Although FIG. 11B illustrates the
individual sets of LED chips as being at different positions along
the axis of the device 100, the surface mountable wLEDs 400 and/or
all LED chips may be placed at substantially the same position
along the device 100 longitudinal axis. For example, in one
embodiment, the wLEDs 400 and other LED chips are placed at the
distal end of the device 100.
[0224] In some embodiments, the .mu.LEDs and uLEDs can be placed at
the end of a flexible device (e.g., a catheter, endoscope,
ureteroscope, hysterocope, laryngoscope, bronchoscope) to enter
body cavities or body lumens and deliver ultraviolet light without
guiding the light from one place to another. For example, the mLEDs
and uLEDs can be placed at the end of a catheter or an endoscope to
treat the lumen of an internal organ. In some embodiments, the LEDs
are placed inside a balloon inside a body cavity. In these
embodiments, the mLEDs can include wavelengths in the visible to
infrared, or from the ultraviolet to visible, or combinations of
wavelengths from the ultraviolet to the infrared.
[0225] There are any number of disease states which can be treated
with devices where LEDs are placed at the point of therapeutic
application and on devices which can be delivered into body
cavities, surfaces, and/or lumens. One example is treatment of
infected indwelling catheters and implants. For example, indwelling
vascular catheters often become infected and have to be removed at
a very high cost to the patients and health care system. A system
of mUV LEDs or uLEDs which emit light in the wavelength range of
about 250 nm to about 400 nm at the region of infection would
eradicate infection within the catheters and obviate or delay the
need to remove the catheters and replace them.
[0226] FIG. 12B illustrates an indwelling catheter 410 which is
used to administer parenteral nutrition (TPN) (for example) to a
patient by providing venous access in a patient. Such a catheter
can also be used for chronic or semi-chronic delivery of
chemotherapy, for dialysis access, or for a variety of additional
applications. Catheter 410 may also be used to provide chronic
implants, such as those used for chronic dialysis access or other
permanent vascular or nonvascular devices. A second catheter 412 is
shown within the indwelling catheter 410. The second catheter 412
has a series of LEDs 414 along its length with corresponding
optical windows 416 in the second catheter 412 which allow for
transmission of sterilizing wavelengths. The therapy (e.g.,
sterilizing wavelengths) can be applied periodically (e.g., on a
maintenance basis to prevent infections from occurring) or the
therapy can be applied at the time of an acute infection. Although
the LEDs are shown at the point of therapy in FIG. 12B, in some
embodiments a light guide is used to transport light some distance
prior to the point of therapy. The light guide can be a flexible
fiber optic light guide with total internal reflection or the light
guide can be more rigid as illustrated in several of the
embodiments above. The LEDs can deliver light to the indwelling
implants from any point along the light guide.
[0227] In another embodiment (not shown), an indwelling vascular
graft is placed in the aorta or peripheral vessels or is used in
dialysis. Similar to the case of indwelling vascular catheters,
indwelling vascular conduits often become infected and lead to
substantial morbidity and mortality in patients. A catheter based
system to deliver ultraviolet light sterilizing therapy to treat
infected indwelling grafts would be highly beneficial and may
obviate or delay the need to remove these implants. Implanted
vascular conduits such as dialysis grafts also become occluded
secondary to a process called restenosis or intimal hyperplasia.
This is a similar process to that seen in smaller vessels such as
coronary arteries when a device such as a stent is placed. Because
of the anti-proliferative properties of UV light (see Perree, et
al., UVB-Activated Psoralen Reduces Luminal Narrowing After Balloon
Dilation Because of Inhibition of Constrictive Remodeling, 75(1)
Photochem. Photobiol. 68-75, which is incorporated by reference), a
device carrying LEDs can be used at the region of the lesion to
treat the lesion and prevent the process of restenosis or intimal
hyperplasia.
[0228] FIG. 12C depicts such a device incorporated into an
optically transparent balloon 418 (e.g., a balloon that is at least
partially transparent to at least some ultraviolet light
wavelengths) to transmit the light directly to a lesion 420. The
balloon 418 is expanded (e.g., with any of the fluids or liquids
known to those of skill in the art) and the light therapy is then
directly applied to the lesion 420 without interfering blood.
[0229] FIG. 12A illustrates an optical therapy device 422 at the
end of a flexible medical device 424, such as an endoscope, a
catheter, or handheld probe. The device 422 can be flexible, as
illustrated in FIG. 12A, rigid or semi-rigid. In addition, the
device 422 or any of the devices described above and below can be
used in conjunction with one or more moieties or agents, such as
psoralen, in a photodynamic therapy system.
[0230] Another embodiment of the present method is referred to as
"internal ultraviolet therapy," and is to treat transplanted
organs. Current treatment for organ rejection is hospitalization
and administration of pharmaceuticals directed to the destruction
of T cells. OKT3 is a monoclonal antibody directed toward CD3
positive cells, a subset of T cells. T cells orchestrate the acute
and sub-acute rejection processes seen in organ rejection.
Antibodies which destroy the T cells can quell the rejection
process. As noted above, ultraviolet light can specifically affect
T cell viability and can therefore be used to treat organ
rejection.
[0231] FIGS. 13A-B illustrates one embodiment of a system to treat
transplanted organs that are being rejected. A catheter 426 with a
light source 126, such as uLEDs or mLEDS, is placed in an artery
leading to a transplanted organ 428 (in this case, a kidney). Since
white blood cells travel substantially along the outer diameter of
blood vessels and the red blood cells travel toward the center,
ultraviolet therapy can be applied more directly and specifically
to the white blood cells (T cells) by implementing the arrangement
shown in FIG. 13B.
[0232] Red blood cells and platelets generally flow in the blood
vessel's flow through lumen 430. The optical therapy device 100 is
generally configured such that it has a lumen in its center for
blood flow therethrough. The surface of the optical therapy device
100 is directed toward the outside of the vessel 432 wherein the
white blood cells and the T cells flow over the surface of the
device. With this device 100 positioned as illustrated in the
cross-sectional view of FIG. 13B, as blood flows past the catheter
100 and along its outer circumference 434, the UV light induces T
cells to undergo apoptosis. The device 100 may be placed in the
artery leading to the transplant organ, or it may systemically lead
to immunosuppression through placement in any vessel of a patient.
In at least this respect, "optical immunosuppression" therapy may
be achieved.
[0233] FIGS. 14A-B illustrate another embodiment of an optical
therapy device used to treat disorders of the external surface of
the eye (e.g., allergic conjunctivitis). Allergic conjunctivitis is
a common clinical problem, and there are few therapies that are
well accepted. Immunosuppressive regimens which involve tacrolimus
(see, Joseph, et al., Topical Tacrolimus Ointment for Treatment of
Refractory Anterior Segment Inflammatory Disorders, 24(4) Cornea
24417-20, which is incorporated by reference) has been used to
treat atopic keratoconjunctivitis, chronic follicular
conjunctivitis, and blepharokeratoconjunctivitis. Ultraviolet light
may be used to treat allergic conjunctivitis by providing a local
therapy to suppress the inflammatory response and immune reaction
against the offending antigen. The optical therapy device for the
eyes is generally configured to prevent ultraviolet rays from
affecting the patient's lens or retina. Other disease states,
including dry eyes, have also been shown to respond to
immunosuppressive drugs such as cyclosporine (see Tang-Liu, et al.,
Ocular Pharmacokinetics and Safety of Cyclosporine, a Novel Topical
Treatment for Dry Eye, 44(3) Clin Pharmacokinetics 247-61 (2005),
which is incorporated by reference).
[0234] In some embodiments, the optical therapy device is used with
a slit lamp to treat patients with allergies such that only the
sclera 435 (see FIG. 14A-B, the portion of the eye affected by the
conjunctivitis) absorbs the UV light and the lens and the retina do
not. The UV is essentially focused onto an area 436 having a hole
438 or region without UV light in the center. The hole 438 in the
center generally corresponds to the location of the pupil 440 and
allows this region to be excluded from the optical therapy. In
another embodiment, such as illustrated in FIG. 14A, a contact lens
436 is provided. In the case of the contact lens 436, a source of
ultraviolet light can be used which does not have a UV sparing
region in its center. In such an embodiment, the contact lens 436
creates the pattern wherein the pupil region is excluded from the
ultraviolet light.
[0235] The mLEDs and uLEDs can be used for therapies such as
psoriasis or other skin disorders currently treated with
ultraviolet light (e.g., vitiligo, cutaneous T cell lymphoma,
fungal infections, etc.). The preferred action spectrum to treat
psoriasis is approximately 308-311 nm. In addition, narrow-band
radiation is generally more effective than broad-band radiation.
One limiting factor in current modalities and technologies for the
treatment of psoriatic lesions is that typical devices available on
the market today are large and expensive, and generally require
patients to visit a physician's office for treatment.
Home-treatment devices are typically large fluorescent lamps that
are adapted to treat a broad area rather than a localized region.
Whether in the home or in the office of the medical practitioner,
the therapy takes time out of the patient's daily schedule. In
addition, it is typically difficult for a patient to perform other
tasks while the therapy is being applied. Furthermore, with current
technology, it is difficult to treat a small area of the skin with
narrowband light. Lasers are sometimes used to do so, but lasers
are generally expensive and are not practical as home-based therapy
devices.
[0236] FIG. 15A depicts one embodiment of the therapeutic device
100 of the current invention applied to a patient's skin 442. The
optical output is similar to any or all of the devices depicted
above and can be narrow-band, broad-band a combination of narrow
band and broadband (for different wavelength regions), or a
combination of multiple narrow-band, and/or broadband, and/or low
or high power white light. The light sources are any of the light
sources in any of the configurations described above. In one
example, the light sources are solid state light sources which, as
described above, are easily portable by the patient and are powered
with a battery pack. The dose of the therapy can be set by an
integrated microcontroller which is programmed by a physician
before the optical therapy device is dispensed. The uLEDs, mLEDS,
and/or wLEDs are used singly or in combination. In one embodiment,
the LEDs are positioned at the end 116 of the probe 107. The probe
can also include a tip 126 which can be purely passive (for
example, a transmissive sheath) or the tip 126 can alter the light
output in some way (for example, a diffusive tip). The output of
the probe 107 in each spectral region can be controlled so that
some LEDs are off while others are on. For example, although a MLED
is placed at the end of the probe 107, if one uLED on the chipset
is activated, the mLED will output only UV wavelength light.
[0237] The therapeutic device 100 can also be used in conjunction
with any of a multitude of moieties as a photodynamic therapy
device, as described above. The diseases of the skin which can be
treated with the therapeutic device 100 include but are not limited
to: vitiligo, psoriasis, atopic dermatitis, mycoses fungoides
(T-cell lymphomas), skin cancers, and infections (e.g., fungal
infections). The device 100 may also contain integrated
photodetectors, which can continuously readjust the device's output
or can detect a disease state of the skin so that the optical
therapy can be applied.
[0238] FIG. 15B shows another embodiment of the therapeutic device
100 in which uLEDs, wLEDs, and/or mLEDs are incorporated into a
device which can be worn or otherwise fixtured, carried or attached
to a patient while the therapy to treat a skin disorder is being
applied. Although the device 100 of the embodiment illustrated in
FIG. 15B has the form of a bracelet, the light source 126 LEDs can
be incorporated into any material which can at least partially
cover or are in direct or indirect contact with the patient's skin
442. For example, the therapeutic device 100 may have the form of a
bandage, blanket, any articles of clothing, a ring, jewelry, a hat,
a wristband, a shirt, a sock, underwear, a scarf, a headband, a
patch, a gauze pad, or any other wearable article, etc.
[0239] In another embodiment, several devices 100 (e.g., bandages)
are brought together or applied to treat a larger area. In one
embodiment, a kit can having different sized bandages is provided.
Adhesive can be a component of the kit and/or a component of the
bandages. The individual sized bandages can be fit together to fit
different shaped and sized areas or plaques. With such a "wearable"
device 100, a patient can treat his or her disorder (e.g.,
psoriasis) while performing other tasks or sleeping and can treat
small or large areas of disease in a time- and cost-effective
manner.
[0240] Such a localized therapy is also safer than treatments which
apply light over a broad area of skin because portions of the skin
which are not psoriatic can be unnecessarily exposed to ultraviolet
light. With the LED systems described above, broad-band or
narrow-band optical therapy can easily be applied to the skin
depending upon clinical requirements. In addition, photodetectors
may be integrated into the therapeutic device 100 for feedback
control of the therapy. Internal body cavities can be treated as
well with permanent or semi-permanent optical therapy devices 100.
For example, in one embodiment, inner ear infections are treated by
placing an optical therapy device 100 inside of the ear canal or a
nasal or para-nasal cavity or airway such as the lungs can be
treated with a permanent or semi-permanent light emitting implant.
In some embodiments, an implant is surgically placed inside a body
cavity or organ such as an intra-abdominal organ or an
intra-thoracic organ. Implants can also be placed in a
genitourinary system such as the bladder, uterus, or vagina to
treat infectious, allergic, and/or inflammatory diseases. An
implant can also be used for contraception. The implant can be
powered by directly contacting the implant with a power source or
through an external power source coupled via electromagnetic
coupling.
[0241] FIG. 15C illustrates an optical therapy device 100 being
applied to a finger or toe nail. In such a case, tinea infections
of the nails may be treated with the device by choosing the
appropriate sterilization wavelengths (e.g., 255-320 nm) for the
uLEDs and mLEDs. FIG. 15D illustrates an optical therapy device 100
used to treat fungal infection of the nail beds 444. The optical
therapy device 100 has the form of a bandage or band-aid. Such a
device 100 allows patients to go about their daily lives while the
treatment is being applied.
[0242] Any of the above devices can be further applied to polymer
curing applications internally or externally to a patient. The
devices can also be used in any context with phosphors which change
the effective wavelength of light. The devices can also be used as
the light activating component of a photodynamic therapy, which
also changes the effective wavelength desired by the optical
device.
[0243] Any of the above devices can also be used in spectroscopic
applications where light (specific wavelength and/or on-off
frequency) is applied to a tissue and then an optical parameter
from the tissue is measured in response to the light application.
The sensor to detect the optical parameter can be incorporated into
the optical therapy device or can be a separate instrument.
[0244] Although this invention has been disclosed in the context of
a certain preferred embodiment, it will be understood by those
skilled in the art that the present invention extends beyond the
specifically disclosed embodiment to other alternative embodiments
and/or uses of the invention and obvious modifications and
equivalents thereof. In particular, while the present optical
therapy devices, systems and methods have been described in the
context of a particularly preferred embodiment, the skilled artisan
will appreciate, in view of the present disclosure, that certain
advantages, features and aspects of optical therapy devices,
systems and methods may be realized in a variety of other
combinations and embodiments. Additionally, it is contemplated that
various aspects and features of the invention described can be
practiced separately, combined together, or substituted for one
another, and that a variety of combination and subcombinations of
the features and aspects can be made and still fall within the
scope of the invention. Thus, it is intended that the scope of the
present invention herein disclosed should not be limited by the
particular disclosed embodiments described above, but should be
determined only by a fair reading of the claims that follow.
* * * * *